BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 270-135-S

    MDR report key: 2945197 · Received January 31, 2013

    Report

    Report Number
    3009089744-2013-00007
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 31, 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

    THIS REPORT HAS BEEN IDENTIFIED AS A B. BRAUN (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(6) 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)(6)): NO INFUSION AFTER 46 HOURS. DRUG: 5FU; CONCENTRATION 5FU: 41.67 MG/ML; DILUENT USE: NACL 0.9%; FILLING VOLUME: 192 ML; STORAGE TEMPERATURE (AMBIENT TEMPERATURE <25 DEGREE C).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42540 EASYPUMP II LT 270-135-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 1M1228EQ13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other