BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE/VAMP COMBINATION KIT

    MDR report key: 2894513 · Received November 2, 2007

    Report

    Report Number
    6000002-2007-53230
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    June 22, 2007
    Report Date
    July 6, 2007
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - ADULT VAMP - VAMP TUBING WAS FOUND TO BE COMPLETELY DETACHED FROM SOLVENT BOND JOINT WITH RESERVOIR. INDICATION OF ADHESIVE WAS VISIBLE AT MOST PART OF TUBING BOND AREA BUT APPEARED TO BE THIN. DETACHED TUBING WAS SEVERELY BENT NEAR THE BOND JOINT.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE/VAMP COMBINATION KIT VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM DXO EDWARDS LIFESCIENCES DR 48VMP120 58278851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other