BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMESCENT INFILTRATION PUMP

    MDR report key: 3637905 · Received February 20, 2014

    Report

    Report Number
    2953189-2014-00022
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    COVIDIEN SAN JOSE
    Product Code
    FRN
    PMA / PMN Number
    K07158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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, FOLLOWING 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. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE FOOTPEDAL KEEPS PUMPING FLUID EVEN WHEN IT IS NOT ON.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DP 20 WAS RETURNED TO NOUVAG USA INC. DURING VISUAL INSPECTION, FAILED FOOT PEDAL CORD WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108236 TUMESCENT INFILTRATION PUMP PUMP, INFUSION FRN COVIDIEN SAN JOSE TPMP-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other