BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMESCENT INFILTRATION PUMP

    MDR report key: 3170803 · Received June 7, 2013

    Report

    Report Number
    2953189-2013-00045
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FRN
    PMA / PMN Number
    K071588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/07/2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH TUMESCENT INFILTRATION PUMP. THE CUSTOMER STATES THAT WHEN THE PUMP IS IN USE, THE TUMESCENT PUMP PART WHERE IT CLAMPS KEEPS OPENING. NO PT INVOLVEMENT. NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253564 TUMESCENT INFILTRATION PUMP PUMP, INFUSION FRN COVIDIEN TPMP-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK