BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO EPUMP - RFB

    MDR report key: 6326920 · Received February 13, 2017

    Report

    Report Number
    3006451981-2017-00177
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 23, 2017
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMITTED: 9/18/2017. AN EVALUATION OF THE KANGAROO JOEY PUMP WAS PERFORMED FOR THE REPORTED CONDITION OF UNDER/OVER DELIVERED; OUTSIDE ACCURATE LIMIT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT AN ADVERSE EVENT OCCURRED WITH AN ENTERAL FEEDING PUMP. THE CUSTOMER REPORTS THE PATIENT WAS OVERFED GREATER THAN 800ML. VOLUME TO BE INFUSED WAS SET TO 1300ML AT 65ML/HR. THE ACTUALLY VOLUME DELIVERED WAS 2100ML WHEN THEY FOUND AN ALMOST EMPTY BAG AT 7:00AM. THE FEEDING BAG WAS CHANGED AT 12 MIDNIGHT. WHICH, ACCORDING TO CALCULATIONS RESIDENT¿¿S FEEDING BAG SHOULD NOT REQUIRE A CHANGE. FEEDING STARTS AT 10AM AT 65ML/HR X20HOURS. PATIENT WAS BEING FED BY G-TUBE WITH A KANGAROO EPUMP ENPLUS WITH FLUSH BAG, ITEM NUMBER AND LOT UNKNOWN. IT IS UNKNOWN HOW LONG THE SET WAS BEING USED PRIOR TO THE INCIDENT. FORMULA WAS FIBERSOURCE. THE PATIENT WAS TRANSFERRED OUT TO ACUTE FOR TREATMENT AND EVALUATION. DIAGNOSIS WAS PNEUMONIA UNSPECIFIED; NEEDED ASPIRATION. THE PATIENT HAS SINCE RETURNED TO THE FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PATIENT WAS OVERFED GREATER THAN 800ML. VOLUME TO BE INFUSED WAS SET TO 1300ML AT 65ML/HR. THE ACTUALLY VOLUME DELIVERED WAS 2100ML. ISSUE WAS NOTICED WHEN THEY FOUND AN ALMOST EMPTY BAG AT 7:00AM. THE FEEDING BAG WAS CHANGED AT 12 MIDNIGHT. WHICH, ACCORDING TO CALCULATIONS BY THE CUSTOMER, THE RESIDENT'S FEEDING BAG SHOULD NOT REQUIRE A CHANGE. FEEDING STARTS AT 10AM AT 65ML/HR X20HOURS. PATIENT WAS BEING FED BY G-TUBE WITH A KANGAROO EPUMP ENPLUS WITH FLUSH BAG, ITEM NUMBER AND LOT UNKNOWN.IT IS UNKNOWN HOW LONG THE SET WAS BEING USED PRIOR TO THE INCIDENT. FORMULA WAS FIBERSOURCE. THE PATIENT WAS TRANSFERRED TO ACUTE FOR TREATMENT AND EVALUATION. DIAGNOSIS WAS PNEUMONIA; NEEDED ASPIRATION. THE PATIENT HAS SINCE RETURNED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108152 KANGAROO EPUMP - RFB ENTERAL FEEDING PUMP LZH COVIDIEN 382401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R