Events

Recall of Terumo Advanced Perfusion System

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
    19740
  • Event Initiated Date
    2016-02-10
  • 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
    Manufacturer has received three reports of a terumo® advanced perfusion system 1 displaying a pressure reading of '999'. terumo cvs has confirmed that in one of these cases, the user was unable to clear the pressure alarm and restart the pump., note: the system displays '999' at pressures greater than +900mmhg. the reading can indicate a true high pressure or a malfunction of the pressure transducer or cable.
  • Action
    Manufacturer to issue advice regarding use

Device

Terumo Advanced Perfusion System

Manufacturer

Terumo Cardiovascular Systems Inc