| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00947-1 |
| Product Name/Description |
The CARDIOHELP-i System
Product code: 701048012
All serial numbers
ARTG 179104
(Getinge Australia Pty Ltd - Heart-lung bypass system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
6/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Getinge has identified two issues with the CARDIOHELP system.
Issue 1:
A production tool (viz. a cable) used to assess leakage current at the sensor panel connection/hub only had connection with 1 out of 16 contacts within that particular connection/hub. Testing with this cable is insufficient and subsequently does not confirm with EN 60601-1 Medical Electrical Equipment standard.
An additional error was identified when investigation issue 1. When the CARDIOHELP Service Manual was created, the measurement of the patient leakage current was not taken into account. This error is unrelated and incidental to the findings in the previous paragraph.
Issue 2:
The IFU states incorrect factory settings, the device itself is working as intended. There is mismatching information regarding PVen, PAux, Venous Bubble Intervention and a false statement regarding deactivated automatic locking in MECC Thapp. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge is advising that affected products can continued to be used as usual.
Issue 1:
Customers will be contacted by Getinge to arrange the Electrical Safety Test according to IEC 62353 of the Cardiohelp-I and subsequent repair, if necessary.
For manufacturer trained Biomedical Engineers, please contact Getinge to arrange the replacement of the current service manual with Revision 10 issue 2023-08.
Issue 2:
Customers are to download and replace the current IFU with revision 1.10.1 date 2023-03 from: https://extranet.getinge.com/assets/download/45357-CARDIOHELP_USERMAN_EN_NONUS.PDF
If a hard copy of the IFU or service manual is required customers are to indicate this on the acknowledgment form a Getinge will arrange delivery of the documents. |
| Contact Information |
1800 438 464 - Quality.AUNZ@getinge.com - Getinge Australia |