BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B BRAUN

    MDR report key: 3905750 · Received June 26, 2014

    Report

    Report Number
    MW5036901
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 25, 2014
    Manufacturer
    B BRAUN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IV BAG CONTAINED 100MG OF MS04/100ML INFUSING AT 1 MG PER ML HUNG BY RN. AT 01:10 AM, THE NIGHT SHIFT NURSE REPORTED THE ENTIRE BAG HAD INFUSED, HOWEVER, THE PUMP READ THAT 8 ML HAD INFUSED (WHICH WOULD BE CORRECT AMOUNT FOR TIME LAPSED BUT THE IV BAG WAS EMPTY). PT HAD NO PHYSICAL EFFECTS OF BOLUS INFUSION. PUMP SEQUESTERED AND TESTING IN PROGRESS BY BBRAUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374424 B BRAUN IV PUMP FRN B BRAUN 8713050U

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR