BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE FOAM DRESSING KIT (MEDIUM)

    MDR report key: 4861703 · Received June 19, 2015

    Report

    Report Number
    3004763499-2015-00004
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    March 8, 2014
    Report Date
    June 17, 2015
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Product Code
    BTA
    PMA / PMN Number
    K122132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4). WOUND CARE MANAGER SERVICED A PATIENT USING THE INVIA LIBERTY DEVICE WITH THE MEDIUM AVANCE FROM DRESSING KIT. DEVICE WAS SET AT -1290. THERE WAS A CLOG AT THE DISTAL END OF THE TRANSFER PAD TUBING. THE CLOG PREVENTED DRAINING FLUIDS TO TRAVEL TO THE DISTAL END OF THE DOUBLE LUMEN TUBING. ACCORDING TO THE PATIENT AND THE WOUND CARE MANAGER THE CLOG WAS DUE TO A CRYSTAL SUBSTANCE USED DURING SURGERY. THE CRYSTAL SUBSTANCE WAS SUCKED INTO THE ESI TUBE PREVENTING FLUIDS FROM PASSING INTO THE DOUBLE LUMEN TUBING; WHICH WAS PREVENTING FLUID FROM COLLECTING IN THE CANISTER. THE WOUND CARE MANAGER CUT THE ESI TUBE WHICH CONTAINED THE CLOG AND REATTACHED THE ESI TUBE TO THE DOUBLE LUMEN TUBING. THIS FIXED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400006 AVANCE FOAM DRESSING KIT (MEDIUM) NPWT POWERED SUCTION PUMP BTA MOLNLYCKE HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1