Events

Safety Alert Or Field Safety Notices for Intra-aortic balloon pump (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 Datascope Corp.

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
    2017-10-03
  • Event Date Posted
    2017-10-03
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/intra-aortic-balloon-pump-iabp-maquet-datascope-cs100-cs100i-and-cs300-potential-for-interruption-or-delay-to-therapy-of-critically-ill-patients
  • 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/gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients.
  • Action
    Note: this MDA is for a different issue to the one described in MDA/2017/027 issued 24 August 2017.Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 17 July 2017. Products distributed from 24 March 2003 to 16 June 2017 inclusive are affected. Use an alternative IABP or an alternative therapy for treatment if available. If no alternative is available, undertake a risk assessment based on a clinical risk-benefit analysis. Affected devices which remain in use should be used in accordance with the manufacturer’s FSN. Contact Maquet to confirm receipt of the FSN and to schedule both the software and hardware updates to prevent false alarms and installation of gaskets to prevent fluid ingress.

Device

Intra-aortic balloon pump (IABP)

Manufacturer

Datascope Corp
  • Manufacturer Address
    Maquet/Getinge Hari Rajendran Post Market Surveillance Manager SSU North Europe QRC/ EMEATelephone: 0191 519 6200hariraj.rajendran@getinge.com
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    MHRA