BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II ST 250-1, 5-S

    MDR report key: 3252400 · Received July 24, 2013

    Report

    Report Number
    3009089744-2013-00176
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    B. BRAUN 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)(6) TO (B)(4) FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): STOP INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345634 EASYPUMP II ST 250-1, 5-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN PRODUCTION LTD. NA 2B1028EZ12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other