| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00678-1 |
| Product Name/Description |
SynchroMed II and SynchroMed EL Implanted Infusion Pump
All models and serial numbers
ARTG Number: 97770 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Clinician Refill Reference Card for SynchroMed Implantable Infusion Systems that was originally distributed with the January 2011 Safety Alert (TGA Ref.: RC-2010-RN-01266-3) related to pocket fills has been updated to align with new product labelling. The January 2011 Medical Device Correction letter provided important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket, instead of the pump which can lead to life-threatening symptoms, serious patient injury, or death due to overdose or underdose. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The main title of the Clinician Refill Reference Card has been updated to read Critical Actions in the Pump Refill Procedure, and the updates to the card include:
- A description of the card’s purpose regarding pocket fill
- A reminder to clinicians of the critical steps for ensuring the pump is correctly refilled
- Detail regarding proper alignment of the refill template
- Information for actions to take if a pocket fill is suspected
- Removal of the note related to glucose testing
Medtronic has updated product manuals and is in the process of deploying the updated labelling. Current labelling for product manuals can be found at www.medtronic.com/manuals.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm . |
| Contact Information |
1800 668 670 - Medtronic Australasia |