BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5354606 · Received January 8, 2016

    Report

    Report Number
    9610825-2015-00695
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Report Date
    December 18, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    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 · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN A(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). WE RECEIVED ONE USED (HALF FILLED) EASYPUMP II LT 270-54-S IN OPEN PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. WE DETECTED NO DAMAGES OR OTHER DEVIATIONS. AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED AND THE PATIENT END CONNECTOR WAS CLOSED WITH THE ORIGINAL WING CAP. FURTHER ON, WE DETECTED LIQUID AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE) OF THE SAMPLE. AFTERWARDS THE PUMP WAS FILLED WITH NACL 0.9 % UP TO THE NOMINAL VOLUME (270 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. THE PUMP DID WORK IMMEDIATELY (SOLUTION WAS RUNNING). LEAKAGES WAS NOT DETECTED AT THE SAMPLE. FLOW RATE TEST: NOMINAL: 5 ML/H ACTUAL: 6.5 ML IN 1 H; 12.9 ML IN 2 HRS; ML 139.9 ML IN 26 HRS. A SLOW FLOW (AS DESCRIBED BY THE CUSTOMER) COULD NOT BE DETERMINED. THE RECEIVED SAMPLE IS WITHIN OUR SPECIFICATIONS. HENCE WE ASSESS THIS COMPLAINT TO BE NOT JUSTIFIED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN-PROCESS AND FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): NO INFUSION. DRUG: 5 FU PFIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12799 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15E18GE271

    Patients

    Seq Age Sex Outcome Treatment
    1