BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES 60ML, 2ML/HR

    MDR report key: 4469219 · Received January 27, 2015

    Report

    Report Number
    2026095-2015-00026
    Event Type
    Malfunction
    Date Received
    January 27, 2015
    Report Date
    December 30, 2014
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICES WILL NOT BE RETURNING FOR ANY OF THE OTHER THERAPY DATES THAT OCCURRED DURING THE 28 DAY TREATMENT. HOWEVER, TWO DEVICES WITH THE SAME MODEL NUMBER WERE RECEIVED, AS REPRESENTATIVE SAMPLES, FOR ANALYSIS. THE DEVICE EVALUATION IS ANTICIPATED, YET NOT BEGUN AT THIS TIME. RESULTS: AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS. THERE ARE NO DEVICE TESTING RESULTS AVAILABLE AS THE INVESTIGATION AND EVALUATION ARE CURRENTLY IN PROGRESS. CONCLUSIONS: ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN - ANP FLOW RATE: 2ML/HR CATHPLACE: STOMACH PLEASE REFERENCE 2026095-2015-00016/14-00005(A), 2026095-2015-00017/14-00005(B), 2026095-2015-00018/15-00005(C), AND 2026095-2015-00029 THROUGH 2026095-2015-00052/15-00005(EE-B). IT WAS REPORTED THAT SEVERAL INCIDENTS OCCURRED WHERE THE INFUSION ENDED SOONER THAN EXPECTED WHILE USING HOMEPUMPS. IT WAS FURTHER DESCRIBED AS, "DID NOT INFUSE PROPERLY FOR 28 DAYS (EACH TIME TOO FAST)". INCIDENT #4 OF 28: INCIDENTS #4-28 WILL REPRESENT THE REST OF THE 28 DAY SERIES OF TREATMENT FOR ONE (1) PATIENT WHERE IT WAS REPORTED THAT THE HOMEPUMPS DID NOT INFUSE AT THE APPROPRIATE FLOW RATE. ANP: ASKED NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63275 HOMEPUMP C-SERIES 60ML, 2ML/HR ELASTOMERIC PUMP MEB HALYARD - IRVINE C060020-10

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR CYMBALTA| B. BRAUN CATHETER 22G| DRUG: LANALINE,