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Terumo Advanced Perfusion System 1 (ABD Module or Occluder Module Malfunction)
- Starting date:
- December 14, 2012
- Posting date:
- January 7, 2013
- 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-16769
Recalled Products
A. Terumo Advanced Perfusion System 1
Reason
Terumo CVS initially received nine reports of malfunction of the ABD module or the occluder module for the Terumo Advanced Perfusion System 1. Its investigation found a faulty component on the modules application board had caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module.
Affected products
A. Terumo Advanced Perfusion System 1
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
801763
Companies
- Manufacturer
- Terumo Cardiovascular Systems Corp.