BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN KANGAROO EPUMP

    MDR report key: 9038935 · Received September 13, 2019

    Report

    Report Number
    3007409280-2019-00011
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 16, 2019
    Manufacturer
    COVIDIEN
    Product Code
    LZR
    PMA / PMN Number
    K143263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOUND THAT THE SIDE PLATE SENSOR WAS BAD CONFIRMING THE REPORTED ISSUE. THE SENSOR PLATE WAS REPLACED. THE CIRCUIT BOARDS WERE INSPECTED. THE DEVICE WAS CALIBRATED. THE DEVICE WAS TESTED ON A SIMULATOR. THE AIR-IN-LINE, ALARM, BATTERY, CONNECTORS, DISPLAY, DOOR AJAR, RATE ACCURACY, AND SELF-TEST/POWER ALL PASSED. THE ROOT CAUSE WAS DETERMINED TO BE THE BAD SENSOR PLATE. THIS WAS RELATED TO THE PREVIOUS REPAIR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION AND INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE HAD A FLOW ERROR. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORTED PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826737 COVIDIEN KANGAROO EPUMP PUMP, INFUSION, ENTERAL LZR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1