BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMESCENT INFILTRATION PUMP

    MDR report key: 3628545 · Received February 14, 2014

    Report

    Report Number
    2953189-2014-00019
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    COVIDIEN SAN JOSE
    Product Code
    FRN
    PMA / PMN Number
    K071588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DP 20 WAS RETURNED TO NOUVAG USA INC. VISUAL INSPECTION RESULTS DETERMINED A FAILURE ON THE PUMP HEAD ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE TUMESCENT PUMP IS PROVIDING AN INCONSISTENT PRESSURE STREAM. THEY PROCEEDED WITH THE PROCEDURE WITHOUT THE PUMP. NO PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97601 TUMESCENT INFILTRATION PUMP PUMP, INFUSION FRN COVIDIEN SAN JOSE TPMP-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other