BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 100-50-S

    MDR report key: 2904655 · Received January 4, 2013

    Report

    Report Number
    3009089744-2012-00021
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 10, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS (B)(4). NO SAMPLE IS AVAILABLE FOR INVESTIGATION. WE ARE AWAITING A STATEMENT FROM OUR MFR. A F/U REPORT WILL BE PROVIDED AFTER THE MFR STATEMENT IS AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(6) SALES ORGANIZATION IN (B)(6)): TWO DIFFERENT PTS - PUMP - NO DIFFUSION. THE DIFFUSER WAS REMOVED 10H AFTER THAT TIME PROVIDED FOR AND DO NOT SEEM TO BE EMPTY WHEN THE PT COMPLETEMENT WE BROUGHT. THE (B)(6) A 14HR THE DIFFUSER POSSE - REVENUE (B)(6) = DIFFUSER "SEEMS NOT TO HAVE DECREASED (PT + IDE) IDE THE HOME AFTER 16H BUT NOT DISTRIBUTED BECAUSE DIFFUSION ENDED (B)(6) AND THE IDE BACK (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4234 EASYPUMP II LT 100-50-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2B2328EH11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other