Events

Recall of ADVANCED PERFUSION SYSTEM 1 - MODULES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO CARDIOVASCULAR SYSTEMS CORP..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    153878
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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 odor of smoke was associated with the failures. the malfunctions occurred during set-up during cardiopulmonary bypass and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed.

Device

ADVANCED PERFUSION SYSTEM 1 - MODULES
  • Model / Serial
    Model Catalog: 803479 (Lot serial: 00366-00498 (802113)); Model Catalog: 802113 (Lot serial: 00366-00498 (802113)); Model Catalog: 803518 (Lot serial: 00216-00283 (802113)); Model Catalog: 803479 (Lot serial: 00216-00283 (802113)); Model Catalog: 802113 (Lot serial: 00216-00283 (802113)); Model Catalog: 803518 (Lot serial: 00123-00214 (802113)); Model Catalog: 803479 (Lot serial: 00123-00214 (802113)); Model Catalog: 802113 (Lot serial: 00123-00214 (802113)); Model Catalog: 803518 (Lot serial: 00080-00121 (802113)); Model Catalog: 803479 (Lot serial: 00080-00121 (802113)); Model Catalog: 802113 (Lot serial: 00080-00121 (802113)); Model Catalog: 803518 (Lot serial: 00066-00077 (802113)); Model Catalog: 803479 (Lot serial: 00066-00077 (802113)); Model Catalog: 802113 (Lot serial: 00066-00077 (802113)); Model Catalog: 803518 (Lot serial: 00047-00064 (802113)); Model Catalog: 803479 (Lot serial: 00047-00064 (802113)); Model Catalog: 802113 (Lot serial: 00047-00064 (802113)); Model Catalog: 803518 (Lot serial: 00
  • Product Description
    SERIAL INTERFACE MODULE RS-232 INTERFACE MODULE FOR CDI SYSTEM 500 SERIAL INTERFACE MODULE RS-485
  • Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.
  • Manufacturer Address
    ANN ARBOR
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    HC