BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 6081817 · Received November 7, 2016

    Report

    Report Number
    9610825-2016-00701
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    October 11, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM COLOMBIA TO BBM IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    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). WE RECEIVED ONE USED, NEARLY EMPTY EASYPUMP II LT 270-54-S WITHOUT PACKAGING. ADDITIONALLY WE RECEIVED A DISPOSABLE HYPODERMIC NEEDLE (21 G, OF A COMPETITOR) WHICH IS CONNECTED WITH THE PUMP. THE PROVIDED PUMP WAS SUBJECTED TO A VISUAL EXAMINATION. AS-RECEIVED CONDITION THE CLAMP CLIP WAS CLOSED AND THE PATIENT CONNECTOR WAS CLOSED WITH THE ORIGINAL WING CAP. AFTER OPENING THE BIG WHITE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE). IN ADDITION, WE DETECTED SOLUTION (LIQUID) AT THE PATIENT CONNECTOR/ORIGINAL WING CAP. FURTHERMORE WE DETECTED A CRACK IN THE LI-CONE OF THE FILLING PORT. MOREOVER, THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY TO A LEAK TEST. THEREFORE THE PUMP WAS REFILLED WITH APPROXIMATELY 150 ML AQUA AD INIECTABILIA BRAUN. AFTER STARTING THE PUMP (OPENING THE CLAMP CLIP) AND WAITING FOR 60 MINUTES THE SAMPLE DID WORK IMMEDIATELY (SOLUTION WAS RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. IN ADDITION, THE FLOW RATE OF THE PUMP WAS TESTED. NOMINAL: 5 ML/H. ACTUAL: 6.1 ML IN 1H; 12.0 ML IN 2 HRS AND 54.1 ML IN 27 HRS (50 % OF THE TOTAL RUNNING TIME). THE FLOW RATE OF THE INSPECTED PUMP IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. THE CRACK IN THE LI-CONE OF THE FILLING PORT IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS, TOO. DEVICE HISTORY RECORDS (DHR): REVIEWED DEVICE HISTORY RECORDS, THERE IS NO ABNORMALITIES AND NO SUCH DEFECT DETECTED AT FINAL CONTROL INSPECTION. HOWEVER, FLOW RATE DEVIATION AND CRACK AT FILLING PORT IS A KNOWN ERROR PATTERN AND CORRECTIVE AND PREVENTIVE ACTIONS ARE IN PROGRESS / HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): INFUSION THERAPY JUST TOO SLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733129 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15D20GE271

    Patients

    Seq Age Sex Outcome Treatment
    1