Events

Safety Alert Or Field Safety Notices for CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Maquet.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-03-07
  • Event Date Posted
    2017-03-07
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/cardiosave-hybrid-intra-aortic-balloon-pump-iabp-and-cardiosave-rescue-iabp-damaged-lithium-ion-batteries-may-give-off-smoke-a-bad-smell-or-produce-sparks
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by maquet – until storage cases are available, avoid carrying spare batteries when transporting the iabp to reduce the risk of dropping and damaging them.
  • Action
    Identify affected batteries: they have part number 0146-00-0097 and were distributed from 12 December 2011 to 9 November 2016.Maquet’s Field Safety Notice (FSN) advises users not to take spare batteries when transporting the IABP until they receive a re-usable transport and storage case.Until the cases are available use an inverter and a transport AC power supply instead of carrying spare batteries.If these power supplies are not available, carry out an individual risk assessment for the continued use of the devices with batteries whilst in transport.Contact Maquet to acknowledge receipt of the FSNArrange for Maquet to provide (free of charge) warning labels to be applied to batteries and re-usable battery transport and storage cases.

Device

CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP
  • Model / Serial
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Manufacturer Address
    Hari Rajendran, Regulatory Affairs Officer, Maquet Ltd Tel: 0191 519 6200Email hariraj.rajendran@getinge.com
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    MHRA