FIELD CORRECTIVE ACTION (FCA) LISTING FOR NOVEMBER 2022

The list below contains Medical Device’s Field Corrective Action for the month of November 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

23 Nov 2022

 Follow Up Communication to Assurity & Endurity Laser Adhesion Field Safety Corrective Action (FA-Q322-CRM-1)

ASSURITY & ASSURITY MRI PACEMAKERS

MDA/FCA/P0135-91376142-2022

GD71875822118

Abbott is providing the following supplemental information for consideration by clinicians in determining the appropriate

course of action for patients:

1. The observed average time to functionality interruption at present is 2.2 years post implant

2.  There is a high degree of statistical confidence (95%) that, if a malfunction were to occur, 99% of devices will present functionality interruption at or after 1.44 years (526 days)

LAW CHING YEE

REGULATORY AFFAIRS & COMPLIANCE MANAGER

ABBOTT MEDICAL (MALAYSIA) SDN. BHD.

1 Nov 2022

 FIELD SAFETY NOTICE – BD Trucount™ Tubes and Kits [BDB-22-4547]

BLOOD CELL COUNT IVD KIT AND CONTROLS

MDA/FCA/P0115-27849456-2022

IVDB71229158618

BD has confirmed through internal investigation that the labels applied to the BD Trucount™ tubes are becoming detached.

Our investigation has identified an adhesive change made at a supplier resulting in the inadequate adhesion. BD is working closely with the supplier to resolve this situation expediently.

NUR AZALEA BINTI MUHAMMAD ZAINAL ASHIKIN

REGULATORY AFFAIRS EXECUTIVE

BECTON DICKINSON SDN BHD

30 Nov 2022

 Field Corrective Action Alpha Active System

ALPHA ACTIVE PUMP SYSTEM

MDA/FCA/P0126-73039459-2022

GMD95507674218A

Arjo has investigated customer complaints where mains cables have been damaged accidently or through miss-use (i.e. incorrectly stowed). Although the mains cables on the Alpha Active models listed have been tested to, and comply with IEC60601-1 Medical electrical equipment

CHONG WAI MUN

GENERAL MANAGER

BEST CONTACT (M) SDN BHD

23 Nov 2022

 Polaris Multimedia - Potentially Missing Securing Element

POLARIS MULTIMEDIA

MDA/FCA/P0121-70251695-2022

GA8379220-38340

During the course of our global market surveillance activities, we have become aware of a case in which the swivel arm of a display dropped from a ceiling tube, whereby it was held in place by internal cabling only.

BEATRICE MAH WAN XIN

QUALITY AND REGULATORY AFFAIR SPECIALIST

DRAEGER MALAYSIA SDN BHD

16 Nov 2022

 B105P/B125P (B1x5P) and B105M/B125M/B155M (B1x5M) patient monitors can display an inaccurate CO2 value when using a gas E-module for CO2 measurement in “mmHg” or “kPa” units when used at locations not at or near sea level.

B105P/B105M/B125P/

B125M/B155M PATIENT MONITOR

MDA/FCA/P0125-91190092-2022

GC3218021-63208

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

LIM SOCK SIANG

DIRECTOR

GE HEALTHCARE SDN. BHD

29 Nov 2022

 NEONATAL, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M

NASAL CANNULA

MDA/FCA/P0142-30077767-2022

GB720571225118

Manufacturer have received reports from their side related to disconnection of the tube from the nasal prong section while using the Neonatal Nasal Cannula with curved prongs and tube.

CHEANG WAI SHAN

SALES MANAGER

KL MED SUPPLIES (M) SDN BHD

25 Nov 2022

 FSCA Oncentra Brachy

FLEXITRON

MDA/FCA/P0139-54017271-2022

GC3716519-29208

In a rare situation, a reconstruction error may be introduced by Oncentra® Brachy to an existing catheter reconstruction, when using the catheter bending functionality. Erroneously placed reconstruction points may

be added that create a double kink in the reconstruction

BHARAT KUMAR A/L VRAJLAL PREMCHAND

DIRECTOR

NYPRAX BUSINESS SOLUTIONS

25 Nov 2022

 A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

MICROSELECTRON

MDA/FCA/P0140-46624467-2022

GC55111585618

In a rare situation, a reconstruction error may be introduced by Oncentra® Brachy to an existing catheter reconstruction, when using the catheter bending functionality. Erroneously placed reconstruction points may be added that create a double kink in the reconstruction

BHARAT KUMAR A/L VRAJLAL PREMCHAND

DIRECTOR

NYPRAX BUSINESS SOLUTIONS

22 Nov 2022

 M5071A Adult and M5072A Infant/child pads cartridges for use with HS1/OnSite/Home AEDs may experience gel separation and reduction of gel surface area

HEARTSTART HS1

MDA/FCA/P0132-45527431-2022

GC78411544718

Some electrode pads used with the HS1/OnSite/Home AED have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself, resulting in reduced surface area of gel on the pad.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

23 Nov 2022

 Ingenia Elition X, Ingenia Elition S, SmartPath to Ingenia Elition X, MR 7700 and ‘Upgrade to MR 7700’ Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

INGENIA ELITION

MDA/FCA/P0136-65349717-2022

GB179941251719

Philips has identified an issue where a specific component failure in the Gradient Coil of where the Affected 3T MR Systems identified in this letter may act as a heat source, with a potential to produce smoke and/or fire.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

23 Nov 2022

 Philips Fetal Spiral Electrode Needle Tip Breaking

AVALON FETAL MONITORS

MDA/FCA/P0138-97367458-2022

GC95268545118

Philips has found that the spiral tip of the FSE may break off during use, potentially requiring surgical intervention to remove the broken tip from the patient.

ZAM ZARINA BINTI MAT ALI

Q&R MANAGER

PHILIPS MALAYSIA SDN BERHAD

9 Nov 2022

 Elecsys CA 19-9: non-reproducible elevated results with certain reagent lots on cobas e 801 and e 402

ELECSYS CA 19-9

MDA/FCA/P0123-32422256-2022

IVDC53289203518

As described in the former versions of MY-FSN-CPS-2020-001, certain Elecsys CA 19-9 lots on cobas e 801 showed in internal investigations and/or customer complaints, an increased rate of non-reproducible elevated results.

KOH WAI CHIN

SENIOR REGULATORY AFFAIRS SPECIALIST

ROCHE DIAGNOSTICS (M) SDN. BHD.

22 Nov 2022

 Unacceptable Light Staining & review of negative results - VENTANA PD-L1 (SP142) Assay Specific Lots

VENTANA PD-L1 (SP142) ASSAY

MDA/FCA/P0133-31318786-2022

IVDC77381365919

VENTANA Medical Systems, Inc. (Roche) observed unacceptable, light staining with some VENTANA PD-L1 (SP142) on-market lots, during internal comparison studies.

KOH WAI CHIN

SENIOR REGULATORY AFFAIRS SPECIALIST

ROCHE DIAGNOSTICS (M) SDN. BHD.

17 Nov 2022

 

Multiple issues concerning VD12A systems Sensis or Sensis Vibe

AX057/22/S, AX058/22/S (FSCA), AX059/22/S (FSN)

 

SENSIS VIBE

MDA/FCA/P0128-86684882-2022

GC26491801918

Issue 1: “PASSWORD STORE CORRUPTED” error message during system bootup

Issue 2: Subsystem crash during examination

Issue 3: Dialog Monitor Computer (DMC) application crash while loading a study

Issue 4: Software crash due to system internal timeout

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

24 Nov 2022

 XP051/22/S Potential risk of foot rest detaching from the patient table

LUMINOS AGILE MAX

MDA/FCA/P0130-84935675-2022

GC74703683318

The CSAN is distributed to inform about a preventive measure to exclude any potential risk of patient injury caused by the foot rest detaching from the patient table during an examination.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

22 Nov 2022

 Intra-Aortic Balloon Pump (IABP), Short Battery Run Times - Advisory Notice

ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM

MDA/FCA/P0134-78584935-2022

GD44414701118

Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices.

CHUAH SIEW SEE

REGULATORY AFFAIRS MANAGER

TELEFLEX MEDICAL SDN.BHD

23 Nov 2022

 

Intra-Aortic Balloon Pump (IABP), Short Battery Run Times

- Advisory Notice

 

AUTOCAT 3

MDA/FCA/P0137-69993396-2022

GD877091305219

Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices.

CHUAH SIEW SEE

REGULATORY AFFAIRS MANAGER

TELEFLEX MEDICAL 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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