Interface Modules (Circuit Board Failure) – Terumo Products

Starting date:

August 9, 2012

Posting date:

September 3, 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, Healthcare Professionals, Hospitals

Identification number:

RA-23847

• Reason
• Affected products

Recalled Products

1. Serial Interface Module RS-232
2. Interface Module for CDI System 500
3. Serial Interface Module RS-485

Reason

Terumo Cardiovascular Systems (Terumo CVS) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the Terumo Advanced Perfusion System 1: Serial interface module RS-232, Serial interface module RS-485, Interface module for CDI System 100/101, Interface module for CDI System 500. Some reports stated that the odour of smoke was associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. The investigation by Terumo CVS has determined that the malfunctions are caused by a circuit board that failed.

Affected products