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Synchromed II - Programmable Pump
- Starting date:
- August 22, 2017
- Posting date:
- September 11, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64492
Reason
The investigation report (IR) for Synchromed II pump corrosion defines the problem statement as the "Degradation of Synchromed II motor components due to corrosion, wear, and a combination of corrosion and wear can result in temporary, intermittent, and/or permanent motor stall." The root cause of failure is identified as the depletion of lubricant at the shaft/jewel bearing interface which initiates mechanical wear on shaft ends, resulting in wear particles that can mix with the remaining lubricant creating residue. Shaft wear results in temporary or permanent motor stall.
Affected products
Synchromed II - Programmable Pump
Lot or serial number
Not Applicable
Model or catalog number
- 8637-20
- 8637-40
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES