Events

Recall of Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution Dual Hemo MCable Pods with Revision Index RI15 and RI16 Manufactured between August 2015 to August 2016

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Australia 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-01269-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01269-1
  • 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
    Dräger has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dräger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. dräger has not received any complaints and is not aware of any negative patient consequences arising from this issue. revisions prior to ri 15 and after ri17 continue to meet the ipx4 standard.
  • Action
    Dräger are advising users to inspect systems to identify any affected products. Dräger will be providing customers with a sleeve to apply in order to prevent the issue from occurring.

Device

Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution...
  • Model / Serial
    Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring SolutionDual Hemo MCable Pods with Revision Index RI15 and RI16Manufactured between August 2015 to August 2016ARTG Number: 138056
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd