BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMESCENT INFILTRATION PUMP

    MDR report key: 2891119 · Received November 14, 2012

    Report

    Report Number
    2953189-2012-00355
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH TUMESCENT INFILTRATION PUMP. THE CUSTOMER STATES THAT WHEN YOU LIFT FOOT OFF OF PEDAL, IT STILL CONTINUES TO PUMP OUT FLUID. THE CUSTOMER TRIED TO TROUBLESHOOT UNIT WITH THE FOOT PEDAL OF ANOTHER PUMP, BUT IT DID THE SAME THING. NO MEDICAL INTERVENTION OR PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUMESCENT INFILTRATION PUMP TUMESCENT INFILTRATION PUMP FRN COVIDIEN TPMP-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK