Events

Recall of Organ Care System (OCS) Heart system - OCS Heart Console

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Transmedics Pty Ltd.

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
    RC-2017-RN-00724-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00724-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified a potential issue with the ocs heart device that could affect proper operation. in particular, the blood warmer may heat beyond the set limit if the heart perfusion module (hpm) is not installed in the ocs console prior to taking the system out of standby mode. use of the ocs heart device to support an organ at an elevated temperature may result in organ damage and/or turndown of organ for transplantation.
  • Action
    TransMedics will be correcting this issue through an update to the software and Instructions For Use (IFU). In the interim, users are to follow the directions in the Product Information Bulletin provided with the customer letter. The Bulletin describes the recommended sequence for installing the HPM into the OSC Console. In order to ensure proper performance, such as maintaining the configured blood temperature, users are to include the HPM in the system’s Self-Test by installing the HPM in the OCS Heart Console while the system is in Standby Mode.

Device

Organ Care System (OCS) Heart system - OCS Heart Console
  • Model / Serial
    Organ Care System (OCS) Heart system - OCS Heart ConsoleOSC Heart Console Reference Number: 1200Serial Numbers: 2486-1-15132, 2486-1-15129, 4929-4-15182ARTG Number: 146269
  • Manufacturer
    Transmedics Pty Ltd

Manufacturer

Transmedics Pty Ltd
  • Source
    DHTGA