BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE P

    MDR report key: 2963562 · Received February 1, 2013

    Report

    Report Number
    9610825-2013-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM LABORATORY IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION OF (B)(6)): FAULTY INFUSION: IN RECENT DAYS, A DANGEROUS MALFUNCTION WAS FOUND WITH TWO B. BRAUN INFUSOMATS IN THE WARD IN THE CHILDREN'S HOSPITAL. FROM THE UNIT THAT THE AMOUNT WAS GIVEN FOR INFUSION, IT WAS OBVIOUSLY STILL IN THE INFUSION BAG / INFUSION BOTTLE. THE DEVICES WERE OPERATED WITHOUT DROPPER. FOR THE ADMINISTRATION OF CHEMOTHERAPY AND OTHER DRUGS, SUCH AN ERROR FOR THE PATIENT IS POTENTIALLY FATAL. AS AN IMMEDIATE MEASURE ON (B)(4) 2013, THE DEVICES ARE EQUIPPED WITH DROP COUNTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44844 INFUSOMAT SPACE P VOLUMETRIC PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN