BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE LINE

    MDR report key: 4093144 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00343
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EVALUATING THE RETURNED COMPONENT, IT WAS DETERMINED THAT THE CAUSE OF THE PROBLEM IS A MISALIGNMENT OF THE BARREL TO THE VALVE BODY. THIS CREATED A GAP WHICH CAUSED THE LEAK. THE VALVE MANUFACTURER HAS BEEN MADE AWARE AND HAS TAKEN CORRECTIVE ACTION TO RESOLVE THE ISSUE. DUE TO THE LARGE AMOUNT OF VALVES USED IN VARIOUS KITS AND THE FACT THAT THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS COMPONENT, IT WILL BE CONSIDERED AN ISOLATED INCIDENT AT THIS TIME AND WILL BE TRACKED AS PART OF THE COMPLAINT PROGRAM SHOULD ADD'L INCIDENTS ARISE. (B)(4).

    Description of Event or Problem · 1

    ONE WAY VALVE LEAKED AT DOME DURING USE. REPLACED VALVE WITH SORIN VALVE AND FINISHED PROCEDURE. DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506783 VALVE LINE CARDIOPULMONARY DEVICE DWE DATASCOPE CORP BO-T 13904 14916-02

    Patients

    Seq Age Sex Outcome Treatment
    1