BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENA

    MDR report key: 3933955 · Received June 30, 2014

    Report

    Report Number
    3933955
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    February 21, 2014
    Report Date
    June 30, 2014
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE PREVENA WOUND VAC WAS IN PLACE ON THE PATIENT. AS THE NURSING ASSESSMENT WAS PERFORMED AT 0800, THE NURSE NOTICED THE FOAM WAS NOT COMPLETELY COMPRESSED, BUT THE VAC WAS NOT ALARMING. THE DRESSING APPEARED TO BE INTACT. APPROXIMATELY ONE HOUR LATER, THE VAC BEGAN ALARMING THAT THERE WAS AN AIR LEAK. THE DRESSING STILL APPEARED TO BE INTACT, AND SEVERAL TEGADERM DRESSINGS WERE APPLIED OVER THE POSSIBLY LEAK AREAS. SEVERAL ATTEMPTS TO GET THE VAC WORKING AGAIN FAILED. THE PREVENA REP WAS NOTIFIED AND INFORMED THE STAFF TO REPLACE THE UNIT. THERE WAS NO PATIENT INJURY IDENTIFIED. HOWEVER, IT WAS ALSO NOTED THE MANUFACTURER, KCI PUBLISHED A URGENT VOLUNTARY MEDICAL DEVICE CORRECTION LETTER ON (B)(6) 2014 REGARDING REPORTS OF MALE TUBING CONNECTOR MAY BE DIFFICULT TO CONNECT TO THE FEMALE CONNECTOR ON THE CANISTER TUBING OF CERTAIN DRESSINGS SYSTEMS.MANUFACTURER RESPONSE FOR WOUND VAC, PREVENA (PER SITE REPORTER).======================RECOMMENDED DEVICE BE TAKEN OUT OF SERVICE AND CHANGED OUT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378632 PREVENA NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP KCI USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES