BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 7300759 · Received February 27, 2018

    Report

    Report Number
    3006451981-2018-00135
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 18, 2018
    Report Date
    June 14, 2018
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    UDI-DI
    10884521006614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE KANGAROO PUMP WAS PERFORMED AND THE CUSTOMER STATES ¿THE DEVICE HAS A LOW READING.¿ THE UNIT WAS TRIAGED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. THE UNIT DELIVERED ACCURATE AMOUNTS OF FOOD. HOWEVER, THE UNIT DISPLAYED AN INCORRECT AMOUNT OF FOOD VOLUME WAS FED. THEREFORE, THE ROOT CAUSE WAS ISOLATED TO A SOFTWARE ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ISSUE OCCURRED WITH AN ENTERAL FEEDING PUMP. UPON TRIAGE ON (B)(6) 2018 THE SERVICE TECH FOUND THAT THE DEVICE DISPLAYED THAT IT FED ABOVE TOLERANCE DURING A VOLUMETRIC ACCURACY TESTING. THE DEVICE WAS SET TO RUN AT 150ML/HR AND WOULD DO SO FOR 30 MINUTES TO COMPLETE THE VOLUMETRIC ACCURACY TEST. THE DEVICE DELIVERED 72.72ML OF FLUID DURING THE TEST, MEASURED BY MASS AND CONVERTED INTO ML. THE DEVICE DISPLAYED THAT IT FED 88ML OF FLUID. THE DEVICE DELIVERS A PROPER AMOUNT BUT DISPLAYS THAT IT FED OVER THE PROPER TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144301 KANGAROO PUMP, INFUSION, ENTERAL LZH COVIDIEN 382400 10884521006614

    Patients

    Seq Age Sex Outcome Treatment
    1