BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG

    MDR report key: 3772252 · Received April 22, 2014

    Report

    Report Number
    3772252
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    COVIDIEN LLC
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING ENTERIC FEEDING USING THE KANGAROO E PUMP. NEW TUBING AND FEEDING WERE TO BE STARTED. RN HAD DIFFICULTY IN SPIKING THE FEEDING BOTTLE. IT WOULD NOT SCREW INTO PLACE AND LEAKED ALL OVER THE FLOOR. ANOTHER E PUMP SAFETY SCREW SPIKE WITH FLUSH BAG WAS OBTAINED. THE FEEDING BOTTLE INSERTED CORRECTLY THIS TIME. NEXT, THE TUBING PUMP SET WAS INSERTED INTO THE PUMP CHAMBER. THE FINGER TAB WAS PLACED ON THE VALVE, THE STRETCH TUBING PLACED AROUND THE ROTOR AND THE RETAINER INSERTED INTO THE RIGHT POCKET. THE PUMP WAS SET TO PRIME BUT NO FEEDING ADVANCED. THE ROTOR AND VALVE ASSEMBLY WERE MOVING BUT FEEDING WOULD NOT ADVANCE. A NEW PUMP WAS TRIED WITH THIS TUBING AND THE SAME THING HAPPENED. A THIRD TUBING SET WAS TRIED WITH THE SAME FAILURE TO ADVANCE THE FEEDING. THIS EVENT RESULTED IN A DELAY IN NUTRITIONAL THERAPY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244376 KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG PUMP, INFUSION, ENTERAL LZH COVIDIEN LLC * 140340055X
    244377 KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG PUMP, INFUSION, ENTERAL LZH COVIDIEN LLC * 140340055X
    244378 KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG PUMP, INFUSION, ENTERAL LZH COVIDIEN LLC * 140340055X

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR COVIDIEN KANGAROO E PUMP (382400)