BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES 270ML, 5ML/HR

    MDR report key: 4437655 · Received January 16, 2015

    Report

    Report Number
    2026095-2015-00012
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 23, 2014
    Report Date
    December 22, 2014
    Manufacturer
    HALYARD
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ONE OF THE THREE DEVICES USED FOR PT #4 WAS REPORTED TO BE RETURNING FOR EVAL. CURRENTLY, CLARIFICATION HAS BEEN REQUESTED ON THE RETURNING DEVICE AND IS NOT AVAILABLE AT THIS TIME. AT THIS TIME HALYARD IS PENDING RECEIPT OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS IN PROGRESS FOR THE REPORTED LOT NUMBER. RESULTS: AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE DEVICE IS RECEIVED, TESTING WILL BE PERFORMED AND RESULTS WILL BE PROVIDED ONCE COMPLETED. CONCLUSIONS: ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHARMACY IN (B)(6) THAT 7 INCIDENTS OF FAST FLOW OCCURRED USING PUMPS ON 4 DIFFERENT PTS. IT WAS REPORTED THAT 2 OF THE 7 DEVICES ARE AVAILABLE FOR RETURN AND ANALYSIS. PLEASE REFERENCE: 2026095-2015-00006/14-01146 (A), 2026095-2015-00007/14-01146 (B), 2026095-2015-00008/14-01146 (C), 2026095-2015-00008/14-01146 (D), 2026095-2015-00008/14-01146 (E) AND 2026095-2015-00011/14-01146 (F). PT #4 OF 4: INCIDENT #3 OF 3-INFUSION STARTED (B)(6) 2014 AT 12:15PM AND ENDED (B)(6) 2014 AT 6:00PM. THE INFUSION ENDED IN 30 HOURS INSTEAD OF 44 HOURS "DURING 3 CONSECUTIVE CURES OF CHEMOTHERAPY'. MEDICAL CONSEQUENCES WERE GASTROINTESTINAL TOXICITY WITH PAIN, DIARRHEA AND TIREDNESS. ONE OF THE DEVICES FROM PT #4 WAS SAVED FOR RETURN AND ANALYSIS. CURRENTLY, CLARIFICATION HAS BEEN REQUESTED ON THE RETURNING DEVICE AND IS NOT AVAILABLE AT THIS TIME. FILL VOLUME: 220ML, FLOW RATE: 5ML/HR, PROCEDURE: CHEMOTHERAPY AND CATHPLACE: PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40716 HOMEPUMP C-SERIES 270ML, 5ML/HR ELASTOMERIC PUMP MEB HALYARD C270050-10 0201162994

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DRUG: FLUOROURACIL 15MG/ML| NACL 0.9%