FIELD CORRECTIVE ACTION (FCA) LISTING FOR JUNE 2022
The list below contains Medical Device’s Field Corrective Action for the month of June 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 |
|
1 June 2022 |
KALTOSTAT CALCIUM ALGINATE DRESSING |
MDA/FCA/2022-P082 |
GC64531714818 |
During these updates the Central Eastern Europe region IFUs failed to be updated with the additional information and the supplemental neonatal IFU was removed from use |
Norazwa Binti Azmi RA & QA Specialist ConvaTec Malaysia Sdn Bhd |
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3 June 2022 |
MiniMed 640G Insulin Pump MiniMed 780G Pump |
MDA/FCA/2022-P083 |
GC23882493217 GC4190021-62126 |
This FCA was initiated due to damage to pump battery cap contacts that result in loss of power to the pump. The battery cap on MiniMed 600 and 700 series insulin pump consists of a plastic cap and metal contact. Specifically, the metal contact is held by three heat stakes (melt formed) located on the battery cap. The metal contact serves to complete the circuit with the AA battery that provides power to the pump |
Athirah Abu Bakar Regulatory Affairs Specialist Medtronic Malaysia Sdn Bhd |
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5 June 2022 |
FCA Notification on Alinity ci-series System Control Module (SCM) - potential performance issue found in the Alinity ci-series software versions 3.3.3 and lower |
Alinity ci-series System Control Module (SCM) |
MDA/FCA/2022-P084 |
IVDA3247720-46201 |
Abbott has identified a potential performance issue found in the Alinity ci-series software versions 3.3.3 and lower. Abbott is releasing Alinity ci-series software version 3.4.0 to correct this issue. |
Farah Syuhaidah binti Ahmad Jahiddin Abbott Laboratories (M) Sdn. Bhd. |
|
7 June 2022 |
V680: Portable Electric Ventilator |
MDA/FCA/2022-P086 |
GC47771332217 |
The V680 Ventilator has been identified as potentially having the following issue: During dual-limb invasive ventilation, a patient cough of sufficient magnitude to drive circuit pressures above 95 cmH2O for longer than 150 milliseconds may cause a “Vent Inoperative 1008: Machine and Proximal Pressure Sensors Failed” alarm, which will cause the V680 ventilator to cease therapy and the ventilator will not function, however, it will remain powered on. |
Zam Zarina Mat Ail Quality & Regulatory Manager Philips Malaysia Sdn. Bhd. Tel +6019 322 0792 Email [email protected] |
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7 June 2022 |
Valiant Navion Thoracic Stent Graft System |
MDA/FCA/2022-P089 |
GD8644419-29954 |
Recent SAFE-N imaging reviews have identified stent ring detachment as a potential precursor to the development of endoleak and/or stent fracture. |
Wong Wai Yi Associate Regulatory Affairs Specialist Medtronic Malaysia Sdn Bhd |
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9 June 2022 |
MDA/FCA/2022-P090 |
Field Engineer (FE) performed incorrect service procedure for patient speaker replacement on a bright speed table due to missing instructions in service manual and as a result got injured. The FE mistakenly loosened and removed the six screws that fix the hydraulic cylinder to the table’s vertical column, causing the table to abruptly drop. The consequence of the high-energy external mechanical force from the table lacerated and fractured the FE's left arm. The laceration was treated with sutures and the FE was referred to an Orthopedic specialist for the fractured arm. |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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10 June 2022 |
Initial FCA Report on XN Haematology Analyser - burning odor from SP-50 around stain pool area |
Sysmex Haematology |
MDA/FCA/2022-P091 |
IVDB17531114618 |
Customers noticed burning odor from SP-50 around stain pool area. After further investigation it turned out that stain buildup from stain pool was accumulated on the stain pool insert detect sensor, causing short circuit |
Dinesh Vijian Regulatory Affairs Specialist Sysmex (Malaysia) Sdn Bhd |
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11 June 2022 |
Initial FCA Report on ARCHITECT Hemoglobin A1c (A1c) & Alinity c Hemoglobin A1c Reagent Kit (HbA1c) - current set value for Low Linearity Range for the Total Hemoglobin is too low when analyzing whole blood or hemolysate samples with poor sample integrity.
|
1) ARCHITECT Hemoglobin A1c (A1c) 2) Alinity c Hemoglobin A1c Reagent Kit (HbA1c) |
MDA/FCA/2022-P092 |
1) IVDB24013273018 2) IVDB6127219-28113 |
Abbott became aware of the linearity issue on 02MAY2021 during an internal investigation, Problem Reporting System (PRS) PRS05429, of potential improvements to ARCHITECT (LN 04P52) and Alinity (08P43) Hemoglobin A1c (HbA1c) assay performance. Internal data analysis found the current set value for Low Linearity Range for the Total Hemoglobin is too low when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low Total Hemoglobin values, which may lead to the potential for whole blood %HbA1c results to be erratic. |
Farah Syuhaidah binti Ahmad Jahiddin Regulatory Affairs & Quality Assurance Executive Abbott Laboratories (M) Sdn. Bhd. |
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13 June 2022 |
Carestation 750/750c A1 Anesthesia Delivery Systems |
MDA/FCA/2022-P094 |
GC2333221-51495 |
Carestation 750/750c anesthesia delivery systems used with one of the optional auxiliary outlets [ACGO (Auxiliary Common Gas Outlet) or Auxiliary O2+AIR] could trigger a mixer failure under certain conditions. At specific O2 and total flow settings (described below) when using the auxiliary outlets, if there is an occlusion in the nasal cannula or linear circuit (e.g. due to clamping, kinking, blocked circuit, or high resistance), this can cause a mixer failure state. This will persist until the next reboot of the device. |
Benedict Lee GE Healthcare Sdn Bhd Regulatory leader |
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14 June 2022 |
Somatom Definition AS, Somatom Definition Edge, Somatom Drive, Somatom Force |
MDA/FCA/2022-P095 |
(GC18552244817) (GC72839223617) (GC89196147817) |
Sporadic problems with the current software may result in workflow interruptions. |
Nur Ayuni Abas Siemens Helathcare Sdn Bhd |
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14 June 2022 |
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Sensis Vibe |
MDA/FCA/2022-P096 |
GC26491801918 |
With Sensis/Sensis Vibe VD12A the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available |
Nur Ayuni Abas Siemens Helathcare Sdn Bhd |
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16 June 2022 |
FSCA Notification on Merlin Patient Care System - battery longevity overestimation |
Merlin Patient Care System |
MDA/FCA/2022-P097 |
GC71698496117 |
Trend has been observed for complaints reporting battery longevity overestimation. Users observe larger-than-expected drops in remaining battery longevity compared to prior follow-up sessions late in the device’s anticipated life. As of 26 May 2022, 30 of these complaints have resulted in premature explants prior to ERI. Device diagnostics are collected either through Merlin.net, the Merlin Programmer Model 3650, or the Merlin2 Programmer Model 3700 to calculate the remaining pacemaker longevity. |
Sharon Wong Seow Lin Quality Manager Abbott Medical (Malaysia) Sdn. Bhd. |
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20 June 2022 |
FSCA Notification on Multi Modality Imaging System - Installing additional speakers to improve audio communication quality |
Multi Modality Imaging System |
MDA/FCA/2022-P098 |
GC338781143418 |
This document provides installation instructions for the SPECT gantry speakers of AnyScan S DUO, AnyScan S DUO FLEX and AnyScan S TRIO products, where speakers have not been installed during manufacturing. |
Mr Wan Muhammad Hafis QA/RA Executive Abex Medical System Sdn Bhd |
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20 June 2022 |
Avance CS2 and Avance CS2 Pro Anesthesia Systems Aisys CS2 Anesthesia Systems |
MDA/FCA/2022-P099 |
GC72098321117, GC59982267817 |
Avance CS2, Avance CS2 Pro, and Aisys CS2 Anesthesia Systems base can have a crack in a specific location in the rear of the anesthesia system. |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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20 June 2022 |
Avance CS2 and Avance CS2 Pro Anesthesia Systems Aisys CS2 Anesthesia Systems |
MDA/FCA/2022-P100 |
GC72098321117, GC59982267817 |
Certain Aisys CS2, Avance CS2, and Avance CS Pro Anesthesia Systems manufactured from January 1, 2021 to April 23, 2022 can potentially have the O2 & Air cylinder pressure transducers reversed |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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21 June 2022 |
AriaDx Real-Time PCR System |
MDA/FCA/2022-P101 |
IVD1153435916A |
Agilent has been made aware of one incident for the AriaDx Real-Time PCR System where the raw fluorescence data from instrument A was placed into instrument B’s experiment file, while instrument B’s experiment file headers and sample names remained as expected (i.e. the sample names and data are mismatched). Investigations have shown that this data “mismatch” is caused by an unstable network environment and can occur on both AriaDx and AriaMx Real-Time PCR Systems. |
Wei Chen Chew Quality Engineer Agilent Technologies LDA Malaysia Sdn Bhd |
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22 June 2022 |
Centricity Universal Viewer Zero Footprint Client Versions 6.0 SP6 through SP11.4 |
MDA/FCA/2022-P102 |
GB88139558518 |
Safety Issue #1: GE Healthcare has become aware of an issue where Distance and Area measurement values can display inaccurately on images that are scaled down from their original resolution. Safety issue #2: When the image contains non-squared pixels including DICOM Gray Scale Presentation State (GSPS), such as some ultrasound and legacy MR images, all measurements displayed in the viewer as well as the scale marker are inaccurate. |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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27 June 2022 |
SCHILLER DEFIGARD Touch 7 |
MDA/FCA/2022-P103 |
GC11767462517 |
Sometimes, when the device is switched on directly in manual or semi-automatic, defibrillation mode, the wrong ECG lead is selected and the patient ECG signal is not analysed by the SAS shock advice system |
Cheah Siew Vooi Regulatory Affairs & Quality Manager Sciller Asia Pacific Sdn Bhd |
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28 June 2022 |
BELLAVISTA Ventilator |
MDA/FCA/2022-P104 |
GC116641014518 |
Ventilator bellavistaTM yang boleh menghentikan ventilasi dan menjana Penggera Kegagalan Teknikal 305 – “Komunikasi kepada nyahsambung CFB (Technical Failure Alarm 305 – “Communication to CFB disconnected).” |
Noor Faizah Binti Kamarudin Regulatory Affairs Executive Schmidt Biomedtech Sdn Bhd |
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29 June 2022 |
CHOLESTECH LDX SYSTEM |
MDA/FCA/2022-P105 |
IVDB15840341318 |
During the execution of PCP1305 (Design Verification Protocol for LDX Cassettes, Specificity – Interfering Substances), a test failure was observed for one of the interfering substances, bilirubin. Further investigation performed under PCP1305-VERF-004 found that, in the presence of 5 mg/dL of unconjugated bilirubin, the percent bias for the TRG and HDL analytes was greater than 10% |
Winnie Hii Lin Lin Senior Regulatory Affairs Specialist Abbott Diagnostics Health Sdn. Bhd. |
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30 June 2022 |
Field Corrective Action notification FA1265 HVAD™ Battery Performance Update. |
Heartware Ventricular Assist System (HVAD) |
MDA/FCA/2022-P106 |
GD74345985518 |
Medtronic is taking actions to address two separate battery issues: 1) a weld non-conformance has been identified within some batteries that can cause the battery to fail to deliver power, 2) an interaction between the battery software configuration and the battery circuit board can cause electrical faults within some batteries |
Wong Wai Yi Associate Regulatory Affairs Specialist Medtronic Malaysia Sdn Bhd |
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30 June 2022 |
Atellica CH Iron_2 |
MDA/FCA/2022-P107 |
IVDB2257286017 |
Siemens Healthcare Diagnostics Inc. has confirmed the potential for Atellica CH Iron_2 reagent carryover to impact Microalbumin_2 (μALB_2) results. Falsely elevated μALB_2 results are observed when the assay is processed immediately following an Iron_2 test on the Atellica CH analyzer (See Table 2). This issue can impact μALB_2 results for quality control (QC), patient samples and calibrators. |
WILSON NG WEIL SHERN QUALITY TECHNOLOGY EXECUTIVE SIEMENS HEALTHCARE SDN BHD |
