FIELD CORRECTIVE ACTION LISTING FOR DECEMBER 2022

The list below contains Medical Device’s Field Corrective Action for the month of December 2022. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –

  • The return of the medical device to the establishment;
  • Modification of the medical device;
  • Exchange of the medical device;
  • Destruction of medical device; or
  • Specific advice on the use of the medical device. 

If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.

 

Date received

Title of FCA

Affected Medical Device

MDA Reference Number

MDA Registration Number

Description

Local Establishment Contact Detail

7 Dec 2022

 Alinity M System Software

ALINITY M SYSTEM

MDA/FCA/P0150-62294787-2022

IVDB7120020-41682

Abbott has identified 4 potential performance issues:

-In unique scenario, the waste chute flapper was found to not open when the System Solution drawer was closed and locked.

-Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent.

-Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system.

- 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack.

VIOLA SUBHASHINI PETERS

REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER

ABBOTT MEDICAL (MALAYSIA) SDN. BHD.

14 Dec 2022

 Alinity M System Amplification Detection Unit(s) (ADU)  Potential Issues.

ALINITY M SYSTEM

MDA/FCA/P0158-26143443-2022

IVDB7120020-41682

Abbott has identified three potential issues which may have impacted the Amplification Detection Unit(s) (ADU) installed on Alinity m System.

1.Systems which had their ADUs serviced may have an incorrect boardvalue (calibration data file) referenced causing a misconfiguration of the calibration.

2.Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration.

3.Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.

VIOLA SUBHASHINI PETERS

REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER

ABBOTT MEDICAL (MALAYSIA) SDN. BHD.

27 Dec 2022

 

FA-00838 VersaLyse Lysing Solution, PN: A09777

Beckman Coulter has identified a deficiency in the Lysing reagent with the lot of products listed above. According to internal testing performed, the lysis of Red Blood Cells is determined to be insufficient and incomplete after 10 minutes of incubation.

 

IOTEST CONJUGATED ANTIBODY CD56-PC5.5

MDA/FCA/P0178-40041868-2022

IVDC8994021-60298

8 complaints were opened for a lysis deficiency issue:According to the complaints received, the customers observed visually an incomplete lysis after 10 minutes of lysis:

The IFU of VersaLyse states:

o The incubation time for the lysis step is “at least” 10 minutes.

o To verify the efficacy of the lysis with the naked eye. A cloudy preparation and a light

diffraction different than usual is a sign of an incomplete lysis.

NUR AISHAH BINTI ABD AZIZ

RA SPECIALIST

BECKMAN COULTER MALAYSIA SDN. BHD.

27 Dec 2022

 

FA-22045 UniCel DxI Reaction Vessels (RV)

Beckman Coulter has determined that the RV kit lot numbers listed may contain RVs that were deformed during the manufacturing process.  RVs may appear crushed or deformed.

 

ACCESS IL-6

MDA/FCA/P0181-84867267-2022

IVDB2507021-52609

Multiple complaints were observed regarding pinched ringed DxI reaction vessels (RV) manufactured by Nolato Magyarorszag Kft, Hungary. Several customers reported reaction vessels were deformed. This deformation was sometimesnoted only after the RV were loaded onto the instrument.

NUR AISHAH BINTI ABD AZIZ

RA SPECIALIST

BECKMAN COULTER MALAYSIA SDN. BHD.

5 Dec 2022

 Field Corrective Action for Whole Body X-Ray CT Scanner System Supria/Supria 64 (Software Version V3.11/V3.22) with Errors during Scanning if Patient Information Contained Specific Words

SUPRIA

MDA/FCA/P0148-83221887-2022

GC46148481917

Fujifilm Healthcare Corporation has investigated reports on 00003050 error or 00003052 error occurred during scanning if patient information contained specific words. Images are not reconstructed and RawData are not displayed in the list when the error occurred. The error occurs during scanning if the patient information containing the following words is registered.

・ready (e.g. Patient name contains ready such as **ready**.)

・status

・finished

The error occurs only if the above words are entered in lowercase letter and when this phenomenon occurs, user may need to start over from the patient registration.

CHONG WAI MUN

GENERAL MANAGER

BEST CONTACT (M) SDN BHD

9 Dec 2022

 Field Corrective Action for Whole Body X-Ray CT Scanner System Supria/Supria 64 (Software Version V3.22) with Maintenance Code and Expected Value (Time Starting Stopwatch) Issues

SUPRIA

MDA/FCA/P0152-66152088-2022

GC46148481917

Update on the system software version. System software V3.22 → V3.22SP V1.01

CHONG WAI MUN

GENERAL MANAGER

BEST CONTACT (M) SDN BHD

6 Dec 2022

 Phadia™ 200 performance of the ImmunoCAP™ Tryptase assay

PHADIA INSTRUMENTS

MDA/FCA/P0149-85295761-2022

IVDA1670544317

Several customer complaints have been registered to question the accuracy of ImmunoCAP™ Tryptase results obtained on Phadia 200 instruments based on comparison to results for the same samples obtained on other Phadia instruments. Further investigation

has shown that the Phadia 200 instrument does not meet specifications.

APPHIA EU CHIA HUI

SENIOR REGULATORY & QA

BIOMARKETING SERVICES (M) SDN BHD

29 Dec 2022

 Field Corrective Action Report on Mislabeling Used of Safety Symbol on the Primary and Secondary Labelling of EnVision FLEX+ Rabbit (LINKER) (Link) (K800921-2) and EnVision FLEX+ Rabbit LINKER (Dako Omnis) (GV80911-2- 70514602)

DAKO_HISTOLOGY/

CYTOLOGY HISTOLOGY/CYTOLOGY REAGENTS_CLUSTER 2

MDA/FCA/P0186-62116297-2022

IVDB83493297718

Based on our investigation, this is a documented concern and important safety information is available. Inclusion of additional symbols indicating labelling of materials of human origin not of medical concern as appropriate clinical laboratory safety precautions to be used for biological materials regardless of animal/human source.

HOW KIAN MING

MANAGING DIRECTOR

BITA LIFESCIENCE SDN. BHD.

30 Dec 2022

 92400926-FA EMBLEM S-ICD Hydrogen Induced Premature Battery Depletion

LATITUDE™ PROGRAMMING SYSTEM

MDA/FCA/P0162-82435620-2022

GC622381173618

In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts healthcare professionals (HCPs) if an EMBLEM S-ICD exhibits hydrogen-induced accelerated battery depletion.

NOR SYAWALIA BINTI MOHD NOR

REGULATORY AFFAIRS ASSOCIATE

BOSTON SCIENTIFIC (MALAYSIA) SDN BHD

21 Dec 2022

Infinity Central Station (ICS) - Software upgrade

INFINITY CENTRAL STATION WIDE

MDA/FCA/P0171-13872868-2022

GC88553130217

Dräger has become aware of cases in which under specific conditions the Infinity® CentralStation (ICS) watchdog software in VG3.0 does not initiate.

BEATRICE MAH WAN XIN

QUALITY AND REGULATORY AFFAIR SPECIALIST

DRAEGER MALAYSIA SDN BHD

22 Dec 2022

 GE Healthcare requests STOP USE of certain Nuclear Medicine 600/800 series systems until inspected

NM/CT 850

MDA/FCA/P0169-60933036-2022

GC4684221-52967

For certain Nuclear Medicine systems (see FSN), GE Healthcare has become aware that a mitigation may not be correctly implemented. If this is the case, the detector can fall leading to life-threatening bodily injury.

LIM SOCK SIANG

DIRECTOR

GE HEALTHCARE SDN. BHD

23 Dec 2022

 FSN Immediate Software Update Version 4.4 FSN/04/2022

MAQUET SERVO-AIR VENTILATION SYSTEM

MDA/FCA/P0066-30576380-2022

GC66783764118

The manufacturer received complaints that ventilators generated a combination of alarms and displayed error messages such as Technical error 10' (Ventilation stopped), Technical Error 16 (ventilation error), and Technical error 55 (Communication errors) and stopped ventilating.

HUDA TAJUDDIN

REGULATORY SPECIALIST

IDS MEDICAL SYSTEMS (M) SDN BHD

20 Dec 2022

FSN Immediate Software Update Version 4.4 FSN/04/2022

MAQUET SERVO VENTILATION SYSTEM

MDA/FCA/P0168-51528595-2022

GC87295608718

The manufacturer received complaints that ventilators generated a combination of alarms and displayed error messages such as Technical error 10' (Ventilation stopped), Technical Error 16 (ventilation error), and Technical error 55 (Communication errors) and stopped ventilating.

HUDA TAJUDDIN

REGULATORY SPECIALIST

IDS MEDICAL SYSTEMS (M) SDN BHD

13 Dec 2022

 HVAD Hardened Driveline Cover Hindering Driveline Disconnection

HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD)

MDA/FCA/P0153-63227362-2022

GD74345985518

Product Event (PE) 704077821 reported on 18-Nov-2020 that a patient had a controller fault alarm but could not perform a controller exchange due to inability to pull the driveline cover back. The VAD coordinator and the Medtronic Clinical Specialist were unable to pull it back as well.

CHOW SOON YEE

REGULATORY AFFAIRS LEAD

MEDTRONIC MALAYSIA SDN BHD

13 Dec 2022

 FA1290 Evolut PRO+ Valve Infolding

EVOLUT™ PRO+ SYSTEM

MDA/FCA/P0156-79751865-2022

GD8317122-94354

Evolut PRO+ was commercialized first in the United States in October 2019 and subsequently commercialized in regions outside of United States in 2020 and beyond. Infolding occurs when the valve frame folds inward along a vertical line away from the native anatomy and appears as a seam in the frame or as overlapping frame cells on radiographic imaging.

CHOW SOON YEE

REGULATORY AFFAIRS LEAD

MEDTRONIC MALAYSIA SDN BHD

16 Dec 2022

 FA1302 Affinity Fusion Oxygenator Loose/Detached TMA

AFFINITY FUSION OXYGENATION SYSTEM

MDA/FCA/P0160-54326277-2022

GC35280902418

On 25 October 2022, CAPA 595768 was initiated due to an increase in complaints for loose or detached Temperature Monitoring Adapter (TMA) inserts (M941297A001) in the Fusion oxygenator.

CHOW SOON YEE

REGULATORY AFFAIRS LEAD

MEDTRONIC MALAYSIA SDN BHD

21 Dec 2022

 Exchange of Syringe Muzamal Industries Sdn Bhd

SYRINGE WITHOUT NEEDLE

MDA/FCA/P0157-96714765-2022

GA8336621-77564

The affected product has been registered with MDA but has not been evaluated by the customer based on the agreement.

MUHAMMAD MUZA BIN MUHAYEN

CEO

MUZAMAL INDUSTRIES SDN BHD

21 Dec 2022

 Efficia External Paddles (989803196431) not adequately identified when connected to a Philips Efficia DFM100 or HeartStart Intrepid Monitor/Defibrillator

EFFICIA DFM100 DEFIBRILLATOR

MDA/FCA/P0166-72636200-2022

GC15931545518

The external paddles may also be used to obtain an ECG as a quick assessment; however, are not for continuous monitoring.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

21 Dec 2022

 2021-CC-EC-023 - External Paddles (989803196431) not adequately identified when connected to a Philips HeartStart Intrepid Monitor/Defibrillator

HEARTSTART INTREPID

MDA/FCA/P0167-27896670-2022

GC2897720-42451

The external paddles may also be used to obtain an ECG as a quick assessment; however,

are not for continuous monitoring. The Efficia External

Paddles may not be properly identified by an Heartstart Intrepid when connected to the device.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

23 Dec 2022

 2022-CC-EC-010 - Efficia Pads Adapter Cable (989803197111) could unexpectedly fail, preventing cardiac ECG monitoring, defibrillation, synchronized cardioversion, or transcutaneous pacing

EFFICIA DFM100 DEFIBRILLATOR

MDA/FCA/P0170-55092738-2022

GC15931545518

Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators are at risk of failed ECG monitoring, defibrillation, synchronized cardioversion, or transcutaneous pacing when using the affected Efficia Pads Adapter Cables.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

23 Dec 2022

 2022-CC-EC-010 - Efficia Pads Adapter Cable (989803197111) could unexpectedly fail, preventing cardiac ECG monitoring, defibrillation, synchronized cardioversion, or transcutaneous pacing

HEARTSTART INTREPID

MDA/FCA/P0171-45776229-2022

GC2897720-42451

Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators are at risk of failed ECG monitoring, defibrillation, synchronized cardioversion, or

transcutaneous pacing when using the affected Efficia Pads Adapter Cables.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

21 Dec 2022

2021-IGT-BST-018 - Philips Azurion R2.1.x System - APC table lock-up when using Azurion R2.1.x system

AZURION 7

MDA/FCA/P0173-59556256-2022

GC82521235717

Philips has discovered that when pressing or releasing both the APC (accept) button and the Float Tabletop (panning) button at the same time, there is a possibility that the system stops reacting to movement requests (table lock-up) and X-ray imaging becomes unavailable.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

21 Dec 2022

2021-IGT-BST-018 - Philips Azurion R2.1.x System - APC table lock-up when using Azurion R2.1.x system

AZURION BIPLANE

MDA/FCA/P0174-15435984-2022

GC59959884718

Philips has discovered that when pressing or releasing

both the APC (accept) button and the Float Tabletop (panning) button at the same time, there is a possibility that the system stops reacting to movement requests (table lock-up) and X-ray imaging becomes unavailable.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

29 Dec 2022

 FSN SG5341 DEFIGARD Touch 7 - Not able to charge

DEFIGARD TOUCH 7

MDA/FCA/P0180-42905267-2022

GC9551022-105940

If the Defigard Touch-7 is configured to start automatically in Manual defibrillation mode when the On/Off button is pressed, there is a risk of not being able to charge the defibrillator, as the Charge button is inactive.

LIM THIAM HONG

DIRECTOR

SCHILLER ASIA PACIFIC SDN. BHD.

14 Dec 2022

 IMC 23-04 IMMULITE 2000 IMMULITE 2000 XPi Thyroglobulin - Low Health Risk

THYROGLOBULIN

MDA/FCA/P0151-65501944-2022

IVDB55220212018

IMMULITE 2000/2000 XPi Thyroglobulin Kit Lots 431, 432, 433, 434, 435, and 436 exhibit increased imprecision at the low end of the assay (below 10 ng/mL).  There is an increased probability for controls below 10 ng/mL to be outside of the established 2SD range with these kit lots.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

30 Dec 2022

 012 FSCA POC 23-004 epoc Blood Analysis System - Low Health Risk

EPOC BLOOD ANALYSIS SYSTEM

MDA/FCA/P0159-34203983-2022

IVDC7557621-75750

The issue has the potential to affect the recovery of pO2 in quality control (QC) at elevation with barometric pressures <730 mmHg on  epoc System Software sensor configuration 41.1, epoc Host 2 SW Version 3.37.3 and epoc NXS Host SW Version 4.10.6, which were released on 17 October 2022.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

16 Dec 2022

 AX062/22/S Potential boot issue after abrupt shutdown on Artis zee/ Artis Q/ Artis Q.zen systems with software version VD12A

ARTIS ZEE (VD11)

MDA/FCA/P0164-22896038-2022

GC94505212917

In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

16 Dec 2022

 AX062/22/S Potential boot issue after abrupt shutdown on Artis zee/ Artis Q/ Artis Q.zen systems with software version VD12A

ARTIS Q

MDA/FCA/P0165-95847052-2022

GC14977431317

In rare cases, the system may only boot into backup mode

after an abrupt shutdown and not reach full operating

mode.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

22 Dec 2022

 015 CN HC 23-03 ADVIA 360 Control Set (L-N-H)

ADVIA 360 HEMATOLOGY SYSTEM

MDA/FCA/P0177-94368848-2022

IVDB43441112618

Siemens Healthcare Diagnostics Inc. has confirmed through investigation that the ADVIA 360 Control Set Normal level control for Lot B1122 may exhibit hemolysis or deterioration due to a microbial contamination which may result in one or more parameters recovering high out of package insert ranges.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

23 Dec 2022

 

ORTHO® VISION and ORTHO® VISION Max Analysers

Potential for False Positive Results due to Carryover when Only Using the Self-Service Customer Procedures Guide for a Probe Replacement

 

REVERSE DILUENT CASSETTE

MDA/FCA/P0175-68688672-2022

IVDD33166265118

The Self-service Customer Procedure guide contains a note indicating the probe can be replaced without using the software maintenance task. If it is performed this way, the instructions do not instruct the operator to condition the probe (Daily Maintenance) after replacement, which is a required post requisite activity.

MENG TSE LEEAU

MANAGING DIRECTOR

T T MEDICAL MANAGEMENT SDN BHD

29 Dec 2022

 FSCA Notification: AutoPulse Platform (AP) Li-Ion Batteries MODEL 100 - Potential failure mode due to high storage temperature

AUTOPULSE RESUSCITATION SYSTEM

MDA/FCA/P0185-16920971-2022

GC66660965418

OLL Circulation’s Post Market Surveillance team observed an increase in battery complaints starting in May 2022. Customers reported that fully charged batteries were not powering on the AutoPulse Platform

WENNISA THOR HOOI HSIEN

BUSINESS, SUPPORT, EXECUTIVE

ZOLL MEDICAL MALAYSIA SDN. BHD.

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
 

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