BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMESCENT INFILTRATION PUMP

    MDR report key: 3801877 · Received May 9, 2014

    Report

    Report Number
    2183870-2014-00090
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN PLYMOUTH
    Product Code
    FRN
    PMA / PMN Number
    K071588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FO LLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THE REPORTED COMPLAINT. IT APPEARS THAT THE PUMP COUPLING WAS DEFECTIVE DURING USE. CIRCUIT BOARD WAS TESTED 100% AND NO FAILURE WAS DETECTED. ALL FUNCTIONS TESTED 100% TO MANUFACTURING SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT WHEN THEY STEPPED ON THE FOOT PEDAL THE PUMP MOTOR DID NOT RUN ON THE TUMESCENT INFILTRATION PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282034 TUMESCENT INFILTRATION PUMP PUMP, INFUSION FRN COVIDIEN PLYMOUTH TPMP-01

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other