BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESAYPUMP II LT 100-50-S

    MDR report key: 2961235 · Received February 8, 2013

    Report

    Report Number
    3009089744-2013-00017
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(4) TO B. BRAUN (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 INFO BY BBM SALES ORGANIZATION IN (B)(4)): NO INFUSION. INFUSER FILLED WITH 5 FZ (SOURCE: (B)(4)). INFUSER PREVIOUSLY PRIMED WITH GLUCOSE 5%. INFUSOR WAS PLACED ON THE PT, WHO NEVER COULD INFUSE 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54883 ESAYPUMP II LT 100-50-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2C1528EH11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other