BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 125-25-5

    MDR report key: 2974413 · Received February 19, 2013

    Report

    Report Number
    3009089744-2013-00024
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    February 15, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM THE CUSTOMER 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 (B)(4)): INFUSION RUNS TOO FAST. BOTH BATCHES RUNNING TOO FAST, IN SPITE OF CORRECT APPLICATION AND COMPLETE FILLING. WILL SEND REFERENCE PRODUCTS, NOT THE USED SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73290 EASYPUMP II LT 125-25-5 ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2F0528EC12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK