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Terumo Advanced Perfusion System 1 (2013-08-12)
- Starting date:
- August 12, 2013
- Posting date:
- September 27, 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-35893
Recalled products
A. Terumo Advanced Perfusion System 1
Reason
Terumo Cardiovascular Systems (Terumo CVS) has become aware through internal testing that the Terumo Advanced Perfusion System 1 operator's manual does not completely describe the system's centrifugal pump response under certain conditions. Specifically, if the user is adjusting the pump speed using the Central Control Monitor (CCM) or the manual speed knob on the centrifugal control unit at the same time an event occurs (which would activate the coast response mode on the pump).
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.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES