Events

Safety Alert Or Field Safety Notices for Perfusor Space infusion pump

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 B Braun.

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
  • Event ID
    MDA/2013/080
  • Event Number
    CON341212
  • Event Date Posted
    2013-11-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON341212?tabName=allTabs
  • 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
    Risk of interruption of therapy when changing syringe. if an aged battery (4 years or older) is used, the pump may not have sufficient power to perform a syringe change, despite the battery indicator on the pump showing a full charge. this could lead to the therapy unexpectedly stopping. the problem does not arise if the pump is plugged into the mains electrical supply. please see the manufacturer’s field safety notices (technical or clinical).
  • Action
    Ensure all relevant staff are aware of the problem and of the guidance in the Field Safety Notice. Identify and replace or test any batteries that are 4 years or older as detailed in the service manual. During transportation of patients: Do not use a pump with aged batteries, if possible. In all cases make sure a spare battery or pump is available, as detailed in the user manual. Actions by All those responsible for the use or maintenance of the devices.

Device

Perfusor Space infusion pump
  • Model / Serial
  • Product Description
    Perfusor Space infusion pump. The service manual , page 6-3, provides guidance on the identification of pumps with affected batteries.
  • Manufacturer
    B Braun

Manufacturer

B Braun