Events

Field Safety Notices about BBraun Perfusor Space Infusion Pump

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by B. Braun Melsungen AG.

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
    Field Safety Notice
  • Event Number
    SN2014(17)
  • Date
    2014-04-08
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bbraun-perfusor-space-infusion-pump.-priority-2---warning&id=85cff925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The irish medicines board (imb) wishes to remind users of a field safety notice (fsn) issued by b. braun in december 2013. b. braun has identified a risk that when the perfusor space pump is used with an aged battery, that the pump may not have sufficient current to perform a syringe change, despite the battery indicator on the pump showing full charge.  the issue can only occur when the pump is not connected to the mains and presents a risk when the pump is used on battery only.
  • Action
    The IMB would like to remind users to:  (1) Follow the instructions outlined by the manufacturer in the FSN attached.  (2) Identify any batteries (or battery packs) of four years or older.  (3) Contact your Biomedical Engineering Department to arrange for replacement or testing of the battery (battery pack), as outlined in the device service manual.  (4) Always have an additional pump available for infusion of critical medications and during transport of patients.  (5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information.

Device

BBraun Perfusor Space Infusion Pump
  • Model / Serial
  • Product Description
    BBraun Perfusor Space Infusion Pump. Priority 2 - Warning
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG