| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00357-1 |
| Product Name/Description |
SynchroMed II Model 8637 Implantable Drug Infusion Pump
ARTG Number: 97770 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has detected an upward shift in reports of over-infusion, defined as an infusion rate exceeding the programmed rate by more than 14.5% as described in the labelling. When over-infusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn is less than the volume expected. The device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm. Over-infusion can result in a life-threatening overdose and/or drug withdrawal resulting from premature emptying of the pump.
The onset of over-infusion has occurred as early as five months after implant and throughout the service life of the pump. Reports indicate that once a pump has started to over-infuse, infusion rates can continue to increase, in some cases abruptly. The device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. Through the Hazard alert letter, Medtronic is recommending physicians on the appropriate management of patients implanted with the affected SynchroMed II pumps. Medtronic continues to investigate this issue and will be providing updates as more information becomes available. For further information, please refer to http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-140328.htm . |
| Contact Information |
1800 668 670 - Medtronic Australasia Pty Ltd |