BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO E-PUMP RENTAL

    MDR report key: 10899587 · Received November 25, 2020

    Report

    Report Number
    1282497-2020-09661
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 26, 2020
    Report Date
    February 3, 2021
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE KANGAROO PUMP WAS PERFORMED. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. A FUNCTIONAL TEST AND VISUAL INSPECTION WERE COMPLETED, AND THE REPORTED ISSUE IS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE IDENTIFIED. THEREFORE, A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION.  IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN STARTED TO FEED A FORMULA 600 ML SETTING THE FLOW RATE 100 ML/H FROM 12 PM, IT FINISHED FOR 4 HOURS. THERE WAS NO ERROR IN SETTING THE FLOW RATE AND THE PUMP SET WAS DISPOSABLE. THE CUSTOMER STATES THERE IS A PROBLEM WITH THE PUMP. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE IS 600 ML NUTRIENT WAS FED AT 150 ML/H ALTHOUGH 100 ML/H WAS SET. IT WAS CONSIDERED AT 150 ML/H BECAUSE 600 ML WAS FED FOR 4 HOURS. UNKNOWN TYPE OF DELIVERY USED. THE FEEDING SET USED WITH THE PUMP WAS JP 1000ML EPUMP SET PRODUCT CODE 973656 WITH UNKNOWN LOT NUMBER. THE TYPE OF FORMULA USED TO FEED THE PATIENT WAS BALANCED NUTRITION LIQUID DIET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367606 KANGAROO E-PUMP RENTAL PUMP, INFUSION, ENTERAL LZH COVIDIEN 782400R

    Patients

    Seq Age Sex Outcome Treatment
    1