| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00366-1 |
| Product Name/Description |
Prismaflex Control Units
Product Codes: 955052, 114870, 114489, 107493, 113082, 113874
All Serial Numbers of the above product are affected
ARTG Number: 142047
(Baxter Healthcare - Prismaflex - Therapeutic plasma exchange system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a “Voltage Out of Range” malfunction alarm, which causes the device to enter a “safe state” and become inoperable until it is serviced. This failure mode can occur at any time during treatment or outside of treatment.
To date, there have been no reports of serious injury associated with this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Baxter are advising that a service representative will be in contact with customers to schedule the firmware upgrade to rectify this issue.
Until the firmware has been installed, users may continue to use the units that have not exhibited the "Voltage Out of Range" malfunction alarm.
This action has been closed out on 20/04/2021 |
| Contact Information |
1800 229 837 (1800 BAXTER) - Baxter Healthcare |