FIELD CORRECTIVE ACTION (FCA) LISTING FOR APRIL 2022
The list below contains Medical Device’s Field Corrective Action for the month of April 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 |
|
5 April 2022 |
VITEK 2 |
MDA/FCA/2022-P053 |
IVDB82052370619 IVDB10305720-46040 |
During internal bioMérieux testing, a VITEK® 2 software issue was identified whereby results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. |
Mimi Asmida Ridhwan Biomerieux Malaysia Sdn Bhd |
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6 April 2022 |
Xevo TQ Xevo TQD Xevo TQ‐S |
MDA/FCA/2022-P054 |
IVD81401752618A IVDA3194720‐48164 |
After investigation a vulnerability has been found within the NeoLynx or IonLynx processing browser, where the final sample of a batch may have tests not displayed when viewed within the NeoLynx or IonLynx processing browser and in reports generated from the browser. |
Yu Seen Ng Emergo Malaysia Sdn. Bhd. |
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7 April 2022 |
Vivo 45, Vivo 45LS, Nippy 4, Nippy 4+ |
MDA/FCA/2022-P055 |
GC69517810218 GC3362520-49980 |
During an internal bench test of this processor monitoring function, Breas has discovered an exceptional condition where a forced shutdown of one of the processors in the ventilator could cause the ventilator to stop treatment without alarming. The test was performed as a challenge test using a special, internal version of the ventilator firmware, which contains code that is not present in any released version of the firmware. |
Amaliena Somnotec (M) Sdn. Bhd. |
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14 April 2022 |
Initial Report of FA1236 Cobalt_Crome Diagnostic Reset due to Stuck TelB |
CareLink SmartSync Device Manager Crome MRI SureScan Crome HF MRI SureScan Cobalt MRI SureScan Cobalt HF MRI SureScan |
MDA/FCA/2022-P056 |
GD6436621-54363, GD6958021-54359, GD6507621-54621, GD6989721-54361, GC2276920-44558 |
Some Cobalt and Crome devices may encounter a persistent “session-active” flag following the use of inductive telemetry. The persistent session-active flag is the result of a telemetry connection error that can occur when intermittent or disrupted signals manifest while communicating with the device at the end of the telemetry session. Inductive telemetry with a Cobalt/Crome device typically occurs during device interrogation with a CareLink Express™ Mobile reader head. |
Wong Wai Yi Medtronic Malaysia Sdn Bhd Office +603-78838000| |
|
14 April 2022 |
Sensis / Sensis Lite |
MDA/FCA/2022-P057 |
GC58192270417 |
Issue 1 - Software crash during split screen: This software crash might prevent the operator from continuing a study, which may result in a delay in the examination. Issue 2 - Software crash due to system internal timeout: This can prevent the operator from starting or continuing a study and may result in a delay in starting or continuing the examination. Issue 3 – Missing regular reboot of the system may result in frozen vital signs: This may lead to incorrect or insufficient basis for diagnostic or therapeutic decisions. |
Nur Ayuni QUALITY TECHNOLOGY EXECUTIVE SIEMENS HEALTHCARE SDN BHD |
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15 April 2022 |
Atellica IM Total Triiodothyronine (T3) 600T Atellica IM Total Triiodothyronine (T3) 120T |
MDA/FCA/2022-P058 |
IVDB66176172318 |
Siemens Healthcare Diagnostics Inc. has confirmed that Atellica IM analyzers listed in Table 1 may produce inconsistent results for Atellica IM T3 Assay (Triiodothyronine) reagent kit lots ending in numbers below 244 after scanning the Master Curve (MC) Card for reagent lots ending in 244 or above |
ZOE CHOW NGAH CHIANN ASSISTANT MANAGER - QUALITY SIEMENS HEALTHCARE SDN BHD |
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18 April 2022 |
FSCA Initial Report on KARL STORZ Flexible Endoscopes - the required efficacy level of disinfection using CIDEX OPA without any additional process step was not achieved. |
KARL STORZ Flexible Endoscopes |
MDA/FCA/2022-P059 |
Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA as a single step was performed. Testing showed that the required efficacy level of disinfection using CIDEX OPA without any additional process step was not achieved. |
Sarah Woon Operations Manager UMMI Surgical Sdn Bhd |
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18 April 2022 |
ORTHO VISION® Analyzer (BioVue) ORTHO VISION® Max Analyzer (BioVue) |
MDA/FCA/2022-P060 |
IVDD33166265118 |
Ortho Clinical Diagnostics received complaints in which customers obtained unexpected results on their ORTHO VISION analyser. |
Siti Noor Liyana Abd Gani Regulatory Affairs Quality Assurance DiagnostiCARE Sdn Bhd |
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20 April 2022 |
Initial FCA Report on RANDOX CALIBRATOR CKMB - realigned of CK-MB Calibrator CK2393 |
RANDOX CALIBRATOR CKMB |
MDA/FCA/2022-P061 |
IVDC2813712916 |
Randox have realigned CK-MB Calibrator CK2393, lot number 4410CK. |
Mark Ong, Biorex Mannheim Malaysia Sdn Bhd |
|
22 April 2022 |
Heartware Ventricular Assist System (HVAD) |
MDA/FCA/2022-P062 |
GD74345985518 |
Medtronic is writing to provide information on upcoming updates to the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare™ Ventricular Assist Device (HVAD™) system. |
Wong Wai Yi Medtronic Malaysia Sdn Bhd |
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22 April 2022 |
Phadia 200 |
MDA/FCA/2022-P063 |
IVDA1670544317 |
An issue in the Phadia 200 software can cause the pipette to be placed too high above the dilution plate |
Ng Boon Thiam Biomarketing Services (M) Sdn Bhd |
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22 April 2022 |
Arrow Kits |
MDA/FCA/2022-P064 |
Teleflex has received complaints reporting that the introducer needle hub in some Arrow® kits crack under stress during the catheterization procedure. |
Chuah Siew See Teleflex Medical Sdn Bhd |
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26 April 2022 |
FCA Initial Report on CARESCAPE R860 Ventilators - the alarm for Back up batteries in CARESCAPE R860 Ventilators manufactured on or after April 1, 2019 that alerts the u 4455 065ser on battery run time remaining could potentially be inaccurate. |
Datex-Ohmeda CARESCAPE R860 ventilator |
MDA/FCA/2022-P065 |
GC97483321017 |
Back up batteries in CARESCAPE R860 Ventilators manufactured on or after April 1, 2019 and GE Healthcare recommended replacement back up batteries distributed on or after April 1, 2019 for CARESCAPE R860, Engström Carestation and Engström PRO can fail earlier than their estimated life. For these batteries, the alarm that alerts the user on battery run time remaining could potentially be inaccurate. |
Benedict Lee Regulatory leader GE Healthcare Sdn Bhd |
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27 April 2022 |
FCA Initial Report on the on-off suction unit Flow-c anesthesia systems in Maquet 4456 066Flow-I Anesthesia Systems |
Flow-C and Flow-E (Maquet Flow-I Anesthesia System |
MDA/FCA/2022-P066 |
GC25644700318 |
It has come to our attention that the suction unit on/off knob material on the Getinge Flow-c and Getinge Flow-e anesthesia systems have a tendency to crack |
Syahirah Fatini Regulatory Executive IDS Medical Systems (M) Sdn Bhd |
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27 April 2022 |
Elecsys CA 19-9 |
MDA/FCA/2022-P067 |
IVDC53289203518 |
As described in the former versions of MY-FSN-CPS-2020-001, Elecsys CA 19-9 lots 416245, 464449, 483123 (all three expired), 504743 and 568976 on cobas e 801 showed in internal investigations and/or customer complaints an increased rate of non-reproducible elevated results. |
Tiffany Soon Regulatory Affairs Senior Executive Roche Diagnostics (M) Sdn. Bhd. |
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27 April 2022 |
Heartware Ventricular Assist System (HVAD) |
MDA/FCA/2022-P068 |
GD74345985518 |
Medtronic is informing all HVAD customers about a new investigation into a possible performance issue. Medtronic has received 3 confirmed complaints of patients that presented with suspicion of a pump thrombosis; however, upon inspection of the 3 returned pumps a device malfunction was identified. |
Wong Wai Yi Associate Regulatory Affairs Specialist Medtronic Malaysia Sdn Bhd |
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27 April 2022 |
Initial Report on Somatom Force - sporadic interference signals may occur due to an error within the patient table position encoder during patient table position. |
Somatom Force |
MDA/FCA/2022-P069 |
GC89196147817 |
During the transmission of the patient table position information, sporadic interference signals may occur due to an error within the patient table position encoder |
NUR AYUNI BINTI ABAS QUALITY TECHNOLOGY EXECUTIVE SIEMENS HEALTHCARE SDN BHD |
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28 April 2022 |
FCA Initial Report on falsely elevated results when using the Alinity m HBV Assay |
Alinity m HBV |
MDA/FCA/2022-P070 |
IVDC9888620-39112 |
Abbott has received reports of falsely elevated results when using the Alinity m HBV AMP Kit. Data analysis has determined that carryover from a well containing high titer HBV to a neighboring well is a potential contributing factor |
Leon Teo RAQA Manager Abbott Laboratories (M) Sdn Bhd |
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27 April 2022 |
CORTRAK*2 Enteral Access System |
MDA/FCA/2022-P077 |
GA4825520-47748 |
Avanos Medical, Inc. is conducting a voluntary field correction for the CORTRAK* 2 Enteral Access System (EAS) due to reports of 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the CORTRAK* 2 Enteral Access System, since 2015. |
Nur Dalila Umar Quality & Regulatory Executive Global Healthcare Logistics (M) Sdn Bhd |
