BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT

    MDR report key: 1013301 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06166
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REC'D (1) JR SYSTEM. BLOOD WAS VISIBLE INSIDE THE SYSTEM. TUBING WAS COMPLETELY DETACHED FROM SOLVENT BOND JOINT WITH THE STOPCOCK LUER (SHUT-OFF VALVE). INDICATION OF ADHESIVE WAS VISIBLE AT SMALL PART OF TUBING BOND AREA AND APPEARED TO BE THIN. IT DID NOT APPEAR THAT THE ADHESIVE CHEMICALLY ETCHED TO THE SURFACE OF THE BONDING COMPONENTS. TUBING O.D. WAS 110" WHICH WAS WITHIN SPEC. (110" +/- .002" PER DRAWING 111467-003 REV AD).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED DURING PATIENT-SET UP. BROKEN TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT BLOOD SAMPLING KIT DQO EDWARDS LIFESCIENCES VMP306 58400722

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK