BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP - NEW

    MDR report key: 6210708 · Received December 28, 2016

    Report

    Report Number
    3006451981-2016-00743
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Report Date
    August 13, 2018
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE KANGAROO PUMP WAS PERFORMED FOR THE REPORTED CONDITION, THE UNIT HAS A HEATING ISSUE. THE UNIT WAS TRIAGED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER STATES THE UNIT HAS A HEATING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861370 KANGAROO EPUMP - NEW PUMP, INFUSION, ENTERAL LZH COVIDIEN 382400 C1371075

    Patients

    Seq Age Sex Outcome Treatment
    1