BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMESCENT INFILTRATION PUMP

    MDR report key: 3708665 · Received March 28, 2014

    Report

    Report Number
    2953189-2014-00042
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    COVIDIEN SAN JOSE
    Product Code
    FRN
    PMA / PMN Number
    K071588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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, 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)

    Additional Manufacturer Narrative · 1

    TUMESCENT PUMP WAS NEVER RETURNED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE TUMESCENT PUMP MECHANISM IS ACTIVE WITHOUT PEDAL BEING DEPRESSED CAUSING FLUID TO BE DISPENSED FROM TUBING END. NO PATIENT INJURY. PROCEDURE WAS COMPLETED BY HAND INJECTION OF TUMESCENT FLUID.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DP 20 WAS RETURNED TO NOUVAG USA INC. DEFECT ON FOOT PEDAL CORD WAS NOTED. DEFECTIVE FOOT PEDAL CORD WAS THE ROOT CAUSE OF THE DISPENSING OF FLUID WITHOUT THE FOOT PEDAL BEING PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184299 TUMESCENT INFILTRATION PUMP PUMP, INFUSION FRN COVIDIEN SAN JOSE TPMP-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other