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Health product recall

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

  1. Terumo Advanced Perfusion System 1: Operator's Manual, Ultrasonic Air Sensor
  2. 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

    Companies
    Manufacturer
    Terumo Cardiovascular Systems Corp.