BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT

    MDR report key: 2850276 · Received October 26, 2012

    Report

    Report Number
    9610825-2012-00210
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 26, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K081905
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). WE RECEIVED ONE ORIGINAL PACKAGED SAMPLE. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. DAMAGES OR OTHER DEVIATIONS SUCH AS LEAKAGES WERE NOT DETECTED. FURTHERMORE THE FLOW RATE WAS DETERMINED ACCORDING TO THE TEST PLAN. NOMINAL VALUE: 4 ML/H; ACTUAL VALUE: 4.93 ML/H. THE SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. WE ARE AWAITING A STATEMENT FROM THE MANUFACTURER. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN THE (B)(4)): THE REFERRED INFUSION PUMPS ARE FILLED FOR THEIR NOMINAL VOLUME (120 ML) WITH SOLUTIONS DESCRIBED (LEVOBUPICAINE + MORPHINE OR ROPIVACAINE + MORPHINE) AND INSTEAD OF LAST 30 HOURS OF INFUSION, AFTER 22 HR/23 HR ARE ALREADY EMPTY. PTS FELT DIZZY AND HAD SOME RESPIRATORY COMPLAINTS DUE TO A HIGHER DOSE THAN SHOULD RECEIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP II LT ELASTOMERIC INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA 2B2628EF11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other