| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00961-1 |
| Product Name/Description |
Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)
S5 Single Roller Pump 150
Product Code: 10-80-00
Serial Number: 10E06300, 10E06301 and 10E06302
S5 Double Roller Pump 85
Product Code:10-85-00
Serial Number: 10E51883
ARTG Number: 108387 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports received of a "fault in motor controller" alarm message. If this occurs, the pump stops, an audible alarm sounds and a visual alarm is displayed as "fault in motor controller" on the system panel. On some occasions the circuit breaker of the pump on the emergency power pack may also trip. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Cellplex is informing the hospitals to quarantine the roller pumps until the affected components have been replaced by Cellplex. Unaffected roller pumps will be supplied by Cellplex as loan units, if required |
| Contact Information |
03 9799 7444 - Cellplex National Sales |