Events

Recall of DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical 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-2012-RN-01222-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01222-1
  • 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
    There have been reported cases in which the displayed value for the invasive blood pressure measurement of the iacs was lower than the actual patient values were. investigations have shown that liquid ingress in the cable connection of the dualhemo mcable may cause inaccurate measurements. further investigation revealed that this can happen if the dualhemo mcable is used in a non-vertical position or vertically but top down instead of top up, or if it is simply laid down on the floor or on the patient bed and is not adequately positioned.
  • Action
    Drager Medical GmbH is providing an amendment to the instructions for use describing the correct orientation of the DualHemo Mcable when in use.

Device

DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)

Manufacturer

Draeger Medical Australia Pty Ltd