Synchromed II - Programmable Pump (2014-03-05)

Starting date:

March 5, 2014

Posting date:

April 14, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-38997

• Reason
• Affected products

Recalled Products

Synchromed II - Programmable Pump

Reason

Provide important new information regarding overinfusion associated with the Synchromed II Implantable Pump. Overinfusion is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. When overinfusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn from the pump is less than the volume expected.
Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. 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.

Affected products