Events

Recall of TCVS Heart lung machine

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Terumo Cardiovascular Systems Inc.

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
    20239
  • Event Initiated Date
    2016-06-02
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Reason
    Terumo cardiovascular systems (terumo cvs) has received reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities. 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.
  • Action
    Product to be exchanged

Device

TCVS Heart lung machine
  • Model / Serial
    Model: Serial interface module RS-232, Serial interface module RS-485, Interface module for CDI System 100/101, Interface module for CDI System 500, Affected: Interface Module
  • Manufacturer
    Terumo Cardiovascular Systems Inc

Manufacturer

Terumo Cardiovascular Systems Inc