FIELD CORRECTIVE ACTION LISTING FOR SEPTEMBER 2023
The list below contains Medical Device’s Field Corrective Action for the month of September 2023. 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 –
(a) The return of the medical device to the establishment;
(b) Modification of the medical device;
(c) Exchange of the medical device;
(d) Destruction of medical device; or
(e) 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.
|
No |
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
1 |
13 Sept 2023 |
TECHNOPATH MULTICHEM |
MDA/FCA/P0509-87058181-2023 |
IVDC87966397519 |
A customer (professional at a testing laboratory) in Switzerland detected the issue upon receipt of the product Multichem SPlus Level 2 08P88-11. The professional was alerted to the issue due to the content of the control vials leaking through the kit box. When the package was opened the control, vials were cracked at the bottom. Swiss Medic directed Technopath Manufacturing Ltd. to action with a FSCA. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
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2 |
13 Sept 2023 |
ANAEMIA |
MDA/FCA/P0516-39266241-2023 |
IVDB23406205018 |
On 30 August 2023 Beckman Coulter made the decision to conduct a field action on Transferrin OSR6152 Lot # 2573. Beckman Coulter has identified that the Transferrin reagent is not meeting the Instructions for Use (IFU) reagent on-board stability claims causing control failures and/or erroneous patient samples results. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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3 |
20 Sept 2023 |
DRX-REVOLUTION MOBILE X-RAY SYSTEM |
MDA/FCA/P0523-38173996-2023 |
GC52334161417 |
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self-contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable. |
WNG AH LIN BUSINESS ADMINISTRATOR CARESTREAM HEALTH (M) SDN BHD |
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|
4 |
7 Sept 2023 |
Oxylog 3000 plus may not switch to mains supply following battery Operation. |
DRAEGER OXYLOG 3000 PLUS |
MDA/FCA/P0480-47961340-2023 |
GC10673823-145156 |
During the course of our global market surveillance activities, we have become aware of instances where emergency and transport ventilator Oxylog 3000 plus devices stopped ventilation due to a discharged battery. This happened despite the fact they were connected to a main supply after prior battery operation. In those cases, the battery status indication was correct at all times and the specified battery alarms (“Charge int. battery” and “Int. battery discharged”) were brought to the user’s attention correctly. No serious injuries to patients have been reported as a result of this issue. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
|
5 |
15 Sept 2023 |
CENTRICITY PACS (RA1000) |
MDA/FCA/P0518-37816466-2023 |
GB5191623-131514 |
This issue could contribute to an adverse patient outcome. This situation can occur during the following workflow: 1. The acquisition device (such as a DX scanner) obtains the information about the scheduled procedures (also known as orders) including patient demographics, accession number, procedure code, and Study Instance UID from a DICOM Modality Worklist provided by a Radiology Information System (RIS), an EMR, or an interface engine. 2.The technologist incorrectly selects Patient A at the acquisition device when performing a study on Patient B. 3.The technologist identifies this error and tries to address the issue by correcting the Patient Demographics of the study to Patient B, but this action does not change the Study Instance UID. 4.When Patient A arrives, the technologist selects the order for Patient A at the acquisition device and stores the study in PACS. Because the Study Instance UID is the same, the studies for Patients A and B will be merged (ie. both patient A and patient B images will be included) with Patient A’s demographics. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
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|
6 |
21 Sept 2023 |
VENUE GO |
MDA/FCA/P0524-93044906-2023 |
GB9215919-37408 |
GE HealthCare has become aware that some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
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7 |
22 Sept 2023 |
SYRINGE WITHOUT NEEDLE |
MDA/FCA/P0514-97145241-2023 |
GA8289892816 |
Muzamal received a complaint from customer regarding the failure of device effectiveness which is inaccurate volume where the actual volume of liquid in syringe is not match with the scale on the syringe. |
MUHAMMAD MUZA BIN MUHAYEN CEO MUZAMAL INDUSTRIES SDN BHD |
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|
8 |
8 Sept 2023 |
CARDIOSAVE INTRA-AORTIC BALLOON PUMP |
MDA/FCA/P0507-38368812-2023 |
GC2992923-137663 |
Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the following four (4) identified system conditions: Issue 1: Autofill Alarms Issue 2: Gas Loss & Gas Gain Alarms Issue 3: System Over-Temperature Issue 4: Fiber Optic Damage |
HEW SOOK PEI ADMIN MANAGER RBD HEALTHCARE SDN BHD |
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9 |
15 Sept 2023 |
Astral 100/150 – Degraded component may lead to Total Power Failure alarm malfunction |
ASTRAL |
MDA/FCA/P0517-41498412-2023 |
GC65216272017 |
ResMed’s Astral ventilator is designed to deliver a Total Power Failure (TPF) audible alarm for at least 2 minutes to alert the carer/clinician when the ventilator experiences a total loss of power that results in a stop of ventilation. The TPF audible alarm is powered by an electrical component known as a supercapacitor. To monitor performance, this component is tested at each two-year preventative maintenance. |
NAZATUL ASHIKIN BINTI REZUAN SENIOR QUALITY ASSURANCE ENGINEER RESMED MALAYSIA OPERATIONS SDN. BHD. |
|
10 |
11 Sept 2023 |
Cobas EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion. |
COBAS EGFR MUTATION TEST V2 |
MDA/FCA/P0513-84553474-2023 |
IVDC71619177218 |
Roche received complaints from customers reporting the generation of false Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2. In a majority of the escalated cases, it was noted that end users were extracting DNA from more than one 5-micron (um) FFPET section or from sections with varying thicknesses. |
KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD. |
|
11 |
11 Sept 2023 |
AX035/23/S & AX036/23/S Potential issue on Cios Alpha VA30, Cios Spin VA30, Cios Flow VA30 |
CIOS SPIN |
MDA/FCA/P0511-77042251-2023 |
GC898941311719 |
Potentially affected system: Cios Spin VA30 With respect to DIN 6862-3: So far, in 3D mode, information about image orientation regarding “laterality” (i.e., L = left / R = right) cannot be defined and saved with the clinical image by the user. Potentially affected systems: Cios Alpha VA30, Cios Spin VA30, Cios Flow VA30 |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
12 |
11 Sept 2023 |
AX035/23/S & AX036/23/S Potential issue on Cios Alpha VA30, Cios Spin VA30, Cios Flow VA30 |
CIOS FLOW |
MDA/FCA/P0512-44684679-2023 |
GC3259721-67284 |
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|
13 |
11 Sept 2023 |
In2Flow Nasal Cannula plug become detached from the soft part. |
HIGH FLOW NASAL CANNULA |
MDA/FCA/P0505-29127760-2023 |
GB7659521-70138 |
Plug become detached from the In2Flow Nasal cannula during high flow therapy. |
NUR DIANA ABD RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
|
14 |
8 Sept 2023 |
ACL TOP Family 50 Series / ACL TOP 970 CL Potential Sample Misidentification |
ACL TOP FAMILY |
MDA/FCA/P0506-42543728-2023 |
IVDC8262823-138692 |
Potential Sample Misidentification on ACL TOP Family 50 Series |
CHAI AI LIN MANAGER STRAITS SCIENTIFIC (M) SDN BHD |
|
15 |
22 Sept 2023 |
ACL TOP FAMILY |
MDA/FCA/P0525-80378514-2023 |
IVDC8262823-138692 |
Mandatory Parameters P-16.8.00 for the ACL TOP Family, and P-18.6.03 and P-18.8.00 for the ACL TOP Family 50 Series, contain the final mitigations to address the following field actions: Reduction of on-board stability claim from 7 days to 4 days for HemosIL® Liquid Anti-Xa, Reduction of on-board stability claim from 3 days to 24 hours for HemosIL® Homocysteine Controls and updated test definitions to mitigate carryover for HemosIL® Liquid Anti-Xa. |
CHAI AI LIN MANAGER STRAITS SCIENTIFIC (M) SDN BHD |