Events

Recall of Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-00093-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00093-1
  • 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
    Maquet has identified an issue with the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidentally dropped, the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions, battery venting has the potential to create smoke, a foul odour, and sparks. there has been no reported patient harm or adverse events attributable to this issue. there have been 3 reported occurrences of the battery venting when dropped to date.
  • Action
    A Maquet Representative will schedule an on-site visit to affix a “Do Not Drop” label on the battery and provide additional instructions which will indicate to take extra care to avoid dropping the battery. Additionally, Maquet is in the process of providing a re-usable transport and storage case which will allow for the transport and storage of spare batteries. Future shipments of CARDIOSAVE Li-Ion batteries from Maquet will be shipped in the re-usable transport and storage container. Users are advised not to take spare batteries for transport applications, until they are provided with the re-usable transport and storage case.

Device

Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP)
  • Model / Serial
    Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP) Part Number: 0146-00-0097All Li-Ion Batteries distributed from December 12 2011 to November 9 2016ARTG Number: 118266
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA