BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 270-27-S

    MDR report key: 2904657 · Received January 4, 2013

    Report

    Report Number
    3009089744-2012-00019
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 4, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM THE NETHERLANDS TO B. BRAUN MELSUNGEN AG IN GERMANY 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 (TRANSLATION OF USER FACILITY INFO BY (B)(4)): FLOW RATE IS TOO FAST. EASYPUMP WAS EMPTY AFTER 13 HRS IN STEAD OF 22 HRS. THIS HAPPENED 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5078 EASYPUMP II LT 270-27-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 1M0128ED12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other