| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-01520-1 |
| Product Name/Description |
Heater-Cooler Unit HCU 40 - Flow Sensor Malfunction
Model 7010434054
All Serial Numbers below: S/N 90441598
ARTG: 144010
(Getinge Australia Pty Ltd - Heat exchanger, heart-lung bypass) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/12/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge is advising that a malfunction of the flow sensor may cause an error message that prevents further use of the device. The HCU 40 device software supervises the values detected by the flow sensor. A malfunction of the flow sensor generates a signal that is detected by the device firmware as out of range.
To prevent further damage or use of a device where the water flow cannot be monitored, the software causes a shut-off of the affected water circuit not allowing desired patient temperature control by this water circuit. Typically, the use of the device is blocked until the malfunction of the flow sensor is corrected by replacement. The use of the HCU 40 with only one working water circuit is possible.
Users are advised that this issue may lead to delays in treatment and/or prolonged anaesthesia and/or organ damage due to insufficient cooling and/or bleeding due to insufficient re-warming and user inconvenience. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Action to be taken by the user:
1. The use of a HCU 40 with only one working water circuit is possible. As a general precautionary measure in the instruction for use for HCU 40;
2. Always keep a replacement unit on standby in order to ensure continuous full operation in the event of the described flow sensor malfunction; and
3. The update of your HCU 40 system(s) must be performed by authorised Getinge service personnel.
This action has been closed out on 13/04/2021 |
| Contact Information |
1800 438 464 - Getinge Customer Service |