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Terumo Advanced Perfusion System 1 (2013-08-12)
- Starting date:
- August 12, 2013
- Posting date:
- September 19, 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-35739
Recalled Products
Terumo Advanced Perfusion System 1
Reason
Terumo Cardiovascular Systems (Terumo CVS) have received three reports of a Terumo Advanced Perfusion System 1 displaying a pressure reading of '999.' Terumo CVS has confirmed that in one of these cases, the user was unable to clear the pressure alarm and restart the pump.
Note: the system displays '999' at pressures greater than +900mmhg. The reading can indicate a true high pressure or a malfunction of the pressure transducer or cable. The operator's manual for the Terumo System 1 does not provide instruction on how to clear the '999' pressure reading.
Affected products
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