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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 |
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. |
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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. |
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27 Dec 2022 |
FA-00838 VersaLyse Lysing Solution, PN: A09777
|
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. |
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27 Dec 2022 |
FA-22045 UniCel DxI Reaction Vessels (RV)
|
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 |
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 |
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9 Dec 2022 |
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 |
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6 Dec 2022 |
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 |
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29 Dec 2022 |
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. |
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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 |
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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 |
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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 |
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 |
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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 |
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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 |
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13 Dec 2022 |
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 |
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16 Dec 2022 |
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 |
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21 Dec 2022 |
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 |
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21 Dec 2022 |
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 |
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21 Dec 2022 |
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 |
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23 Dec 2022 |
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 |
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23 Dec 2022 |
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 |
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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 |
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. |
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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 |
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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 |
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16 Dec 2022 |
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 |
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16 Dec 2022 |
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 |
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22 Dec 2022 |
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 |
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23 Dec 2022 |
ORTHO® VISION and ORTHO® VISION Max Analysers
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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 |
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29 Dec 2022 |
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. |
