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FIELD CORRECTIVE ACTION (FCA) LISTING FOR MARCH 2022
The list below contains Medical Device’s Field Corrective Action for the month of March 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 |
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3 March 2022 |
M5071A (adult) and M5072A (infant/child) pads |
MDA/FCA/2022-P024 |
GC78411544718 |
When a pad with separated, folded gel is placed on the patient’s bare skin, the HS1/OnSite/Home AED could deliver less effective or ineffective therapy to the patient due to the reduced surface contact area with the skin. |
Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email zam.zarina@philips.com |
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4 March 2022 |
Atellica® Solution and ADVIA Centaur® Systems Affected Product(s) |
MDA/FCA/2022-P025 |
IVDB84090171418 IVDB84090171418 IVDB4853331017 IVDB4853331017 |
Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens with the Atellica IM Enhanced Estradiol (eE2) assay. Results demonstrate that plasma specimens are not meeting claims as defined in the Instructions for Use (IFU). |
Wilson Ng Quality & Technology Siemens Healthcare Sdn. Bhd. |
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7 March 2022 |
Vessel Sealer Extend, SynchroSeal |
MDA/FCA/2022-P026 |
GC3810021-64842 |
placing excessive tissue in the instrument jaws of the Vessel Sealer Extend or SynchroSeal instruments prior to sealing and transection can result in an insufficient seal resulting in either immediate or delayed bleeding. |
Li Fang Tan Regulatory Affairs Associate DTG Medical |
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7 March 2022 |
Fore-Sight Elite Tissue Oximeter Module |
MDA/FCA/2022-P027 |
GC766371236819 |
When using the large sensors in certain somatic locations (arms and legs), the StO2 values will be inaccurately low. The low StO2 values are noticeable upon start-up. Inaccurate values can lead to inappropriate/unintended treatment. Adult cerebral and flank/abdomen locations and all paediatric locations are not impacted. |
Chiew Chee Hoe Sr. Regulatory Affairs Specialist Edwards Lifesciences, Malaysia Sdn. Bhd. B03-A-15-01, Menara 3A, No 3, Jalan Bangsar, KL Eco City, 59200, Kuala Lumpur. |
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8 March 2022 |
AR176 Artisan Grocott's Methenamine Silver (GMS) Stain Kit Box 1 & 2 |
MDA/FCA/2022-P028 |
IVDB12848297618 |
Some customers reported strong fungal staining in both control tissue as well as patient tissue with the Lot numbers 11302633, 11311107, 11316517 and 11326608 |
Nurul (Regulatory Affairs Executive) Bita Lifescience Sdn Bhd |
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9 March 2022 |
FCA Report_CVG-22-Q1-02 Reveal LINQ with TruRhythm™ Insertable Cardiac Monitoring Systems |
Carelink Programmer For cardiac implantable device CareLink Encore Reveal and Reveal LINQ Insertable Cardiac Monitor |
MDA/FCA/2021-P029 |
GC225231049318, GD39137784918, GD89249865118 |
Medtronic has identified that Reveal LINQ with that undergo a partial electrical reset appear to be programmed “ON,” but are no longer able to detect and report Brady and Pause events |
Wong Wai Yi Medtronic Malaysia Sdn Bhd Office +603-78838000 Email: wong.waiyi@medtronic.com |
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9 March 2022 |
PHADIA AB immunochemistry Allergy |
MDA/FCA/2021-P030 |
IVDB4145881517 |
Small deformations of capsules may occasionally occur during manufacturing. Small deformations may cause capsules to get stuck in the carrier, which can lead to dispensing problems and generate error messages in the Phadia instruments |
Najah Suadah Zakaria Regulatory & QA Executive Biomarketing (M) Sdn Bhd |
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9 March 2022 |
Initial Report FSN on 2021-IGT-BST-030 - Azurion R1 - x correction for Patient Type issue. |
Azurion 7 B20 Azurion 3 M15 Azurion 7 B12 Azurion 7 M12 Azurion 7 M20 |
MDA/FCA/2021-P031 |
GC59959884718 GC82521235717 GC99381544218 |
A change in the patient type could lead to Image Quality Degradation (in case that the radiation dose is too low) or additional X-ray dose for the patient (when the radiation is higher than the one required). No harm is expected from the additional radiation dose |
Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email: zam.zarina@philips.com |
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11 March 2022 |
Initial Report FSN on Oncentra® Brachy - the applicator model may get mirrored. |
FLEXITRON |
MDA/FCA/2022-P032 |
GC3716519-29208 |
In two rare scenarios, the applicator model may get mirrored. This is caused by a design fault in the mapping of the applicator model to the user provided anchor point. If unnoticed, this could result in a difference between the planned and delivered dose. |
Mr Hafis QA/RA Executive Abex Medical System Sdn. Bhd |
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15 March 2022 |
Maquet Servo Ventilation System |
MDA/FCA/2022-P033 |
GC87295608718 |
For ventilators operating at mains power voltage 220V-240V, Maquet Critical Care have identified that a current-limiting resistor on the AC/DC Power supply board (PC 1995) may degrade over time, and prevent the AC/DC from performing as specified. |
Ms Syahirah Fatini IDS Medical Systems (M) Sdn Bhd |
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15 March 2022 |
Merlin Patient Care System |
MDA/FCA/2022-P035 |
GC71698496117 |
Under normal system usage, the issue described in the HHE will not be encountered, and the test will end upon user request. However, if the user runs a decrement capture test and attempts to cancel the test prior to the first decrease in amplitude, they may encounter this issue. |
Ms Sharon Wong Abbott Medical (Malaysia) Sdn. Bhd. |
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16/3/2022 |
Dimension® Total Protein/Albumin Calibrator |
MDA/FCA/2022-P036 |
IVDB8603225917 IVDB6230274717 |
Siemens Healthineers has confirmed that the Dimension Total Protein/Albumin Calibrator (TP/ALB CAL) listed in Table 1 has an incorrect expiration date (2022-01-10, January 10, 2022) listed in the Instructions For Use (IFU) and incorporated in the 2D barcode contained within the IFU. |
Mr Wilson Ng Siemen HEALTHCARE SDN BHD |
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17/3/2022 |
Initial Report of FCA - Stratus CS 200 & Stratus CS Rotor Shelf-Life Extension |
Rotors |
MDA/FCA/2022-P037 |
IVDA77490195818 |
Siemens Healthcare Diagnostics Inc. determined that the shelf-life of those rotors can be extended by 3 months and 2 weeks, given further review of product stability data. |
Mr Wilson Ng SIEMENS HEALTHCARE SDN BHD |
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17 March 2022 |
BV Endura Release 2.3 BV Pulsera Release 2.3 Veradius Unity Release 2.1 |
MDA/FCA/2022-P038 |
GC16937716718 GC46581836318 GC64557742818 |
Philips has identified that the Instructions for Use of these products do not specify the maximum surface temperature of the X-ray tank |
Mrs Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email zam.zarina@philips.com |
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17 March 2022 |
FSN Initial Report on 2021-IGT-PUN-001-Intuis - Additional Regulatory Information – System Component Temperature |
Philips Intuis |
MDA/FCA/2022-P039 |
GC25539161917 |
Philips has identified that the Instructions for Use of these products do not specify the maximum surface temperature of the X-ray tank |
Mrs Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email zam.zarina@philips.com |
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17 March 2022 |
Philips BV Vectra |
MDA/FCA/2022-P040 |
GC27533129017 |
Philips has identified that the Instructions for Use of these products do not specify the maximum surface temperature of the X-ray tank |
Mrs Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email zam.zarina@philips.com |
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17 March 2022 |
FCA Initial Report on Atellica UAS 800/ 1500 Device Door Gas Spring Failure |
Atellica UAS 800 Analyzer |
MDA/FCA/2022-P041 |
IVDB43102172618 |
Siemens Healthcare Diagnostics has confirmed that the door gas spring which holds the analyzer door open is failing before its specified lifetime |
Mr Wilson Ng Siemen Healthcare Sdn Bhd |
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18 March 2022 |
FCA Initial Report on 2021-CC-HRC-003 - V60/V60 PLUS/V680 Ventilators - 35V Rail. |
V60/V60 Plus/V680 Ventilator |
MDA/FCA/2022-P043 |
GC47771332217 GC26388685318 |
All V60/V60 Plus and V680 units have been identified to have potential issue that could affect the main electrical circuit (“35V Rail”) powering the ventilator and alarm |
Ms Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email zam.zarina@philips.com |
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18 March 2022 |
Remel™ Culti-Loops™ Candida albicans ATCC ™ 10231 ™ PK/5 |
MDA/FCA/2022-P044 |
IVDB8212720-43836 |
An internal investigation has found that R4601503 lot 294388 is not performing as expected. |
Ms Gan May Ping Thermo Scientific Microbiology Sdn. Bhd. |
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22 March 2022 |
MUSE NX Cardiology Information System |
MDA/FCA/2022-P046 |
GB8813220-41745 |
Edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. |
Mr Benedict Lee Regulatory leader GE Healthcare Sdn Bhd |
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24 March 2022 |
FCA Initial Report of Sureform 45, Sureform 45 curved tip & Sureform 60 - tissue pushout events |
Sureform 45, Sureform 45 curved tip & Sureform 60 |
MDA/FCA/2022-P047 |
GC3810021-64842 |
Intuitive initiated a review of complaints on SureForm PNs 480445, 480545, 480460 to determine rate of harm due to tissue pushout events. This action was completed as partof an internal CAPA. |
Ms Tan Li Fang Regulatory Affairs Associate DTG MEDICAL SDN.BHD. |
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25 March 2022 |
Alinity I Homocysteine Reagent kit |
MDA/FCA/2022-P048 |
IVDC10485419-29133 |
Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control results |
Ms Farah Syuhaidah binti Ahmad Jahiddin Abbott Laboratories (M) Sdn. Bhd. |
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26 March 2022 |
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VITROS Immunodiagnostic Products FSH Reagent Pack (1931922) VITROS Immunodiagnostic Products LH Reagent Pack (1350198) VITROS Immunodiagnostic Products Prolactin Reagent Pack |
MDA/FCA/2022-P049 |
IVDB18875152118 |
Ortho Clinical Diagnostics has observed an increase in complaints, and confirmed observed imprecision, for low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Complaints have also been received regarding calibration failures, driven by imprecision observed with Calibrator Level 1. |
Ms Siti Noor Liyana Abd Gani Regulatory Affairs & Quality Assurance Senior Executive DiagnostiCARE Sdn. Bhd. |
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30 March 2022 |
Advanta V12 Vascular Covered Stent |
MDA/FCA/2022-P050 |
GD56085853618 |
an increased of customer complaint rate related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal. |
Ms Chan Liy Hui Regulatory affairs Edaran Bio-Medik Sdn Bhd |
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31 March 2022 |
Puritan Bennet 980 Ventilators |
MDA/FCA/2022-P052 |
GC95166567018 |
Medtronic received complaints alleging that PB980 ventilators did not annunciate an audible alarm during active alarm conditions |
Ms Mariani Masjidan Medtronic Malaysia Sdn Bhd |
