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Terumo Advanced Perfusion System 1: Operator's Manual, Ultrasonic Air Sensor
- Starting date:
- September 14, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15909
Recalled Products
- Terumo Advanced Perfusion System 1: Operator's Manual, Ultrasonic Air Sensor
- Manufacturer
- Terumo Cardiovascular Systems Corp.
Reason
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports of false alarms generated by the air bubble detection system used with the terumo advanced perfusion system 1, the SARNS Modular Perfusion System 8000 and the SARNS Perfusion System 9000. Terumo CVS' investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. Therefore, Terumo CVS has concluded that it is necessary to amend the operator's manuals for its heart-lung machines to:
- alert all users of the potential for a malfunction of the air bubble detection system
- reinforce the mitigation procedures in the event of a malfunction.
Affected products
A. Terumo Advanced Perfusion System 1: Operator's Manual, Ultrasonic Air Senso
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
801763