BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT

    MDR report key: 1082665 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-07979
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    K925638
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CUSTOMER REPORT WAS CONFIRMED. VAMP TUBING WAS FOUND TO BE COMPLETELY DETACHED FROM SOLVENT BOND JOINT WITH SAMPLE SITE (Z-SITE). AT SOME PART OF TUBING BOND AREA INDICATION OF BONDING SOLVENT WAS PRESENT BUT APPEARED TO BE THIN. AND IT DID NOT APPEAR THAT THE ADHESIVE CHEMICALLY ETCHED TO THE SURFACE OF THE Z-SITE TUBE HOUSING. TUBING O.D. WAS .139" WHICH WAS ON THE LOWER SIDE OF THE SPEC. (141"+/-.002" PER DRAWING 111467-001 REV. AD).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD SEPARATED FROM Z SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES PXVMP160 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK