BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 2810194 · Received October 19, 2012

    Report

    Report Number
    9610825-2012-00214
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 19, 2012
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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) (MANUFACTURER). (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(4) TO (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 (B)(4)): RECOGNIZED INCORRECT SYRINGE: IT APPEARS THAT THE USER HAS LOADED A BD 30 ML SYRINGE, BUT THE PUMP HAS RECOGNIZED IT AS A BD 50 ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSOR SPACE SYRINGE PUMP FRN B.BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other