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 III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-35879

• Reason
• Affected products

Recalled products

A. Terumo Advanced Perfusion System 1 

Reason

Terumo Cardiovascular Systems (Terumo CVS) has become aware that under certain circumstances, a Terumo Advanced Perfusion System 1 Centrifugal pump "service pump" message may display  due to user induced motor movement.  In this instance, the Terumo System 1 will recognize the movement (as it is designed to do} and display a "service pump" message. The user might interpret this message as a pump that requires service rather than a message displayed due to pump movement while not activated. Because of these instructions,   the user may unnecessarily remove and replace a properly functioning piece of equipment (if the message was due to a user-induced action).

Affected products