BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESEP CENTRAL VENOUS OXIMETRY SET

    MDR report key: 2853403 · Received November 30, 2012

    Report

    Report Number
    2015691-2012-18736
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    ONE TRIPLE LUMEN PRESEP CATHETER WAS RECEIVED IN AN OPEN TRAY FOR EVALUATION. THE CATHETER AND ALL COMPONENTS OF THE OPEN TRAY DID NOT APPEAR TO BE USED. CUSTOMER REPORT OF HAIR ON THE PREP BOWL WAS CONFIRMED. EXAMINATION OF THE TRAY FOUND WHAT APPEARED TO BE A HAIR-LIKE PARTICULATE IN THE OPTIC CONNECTOR SECTION OF THE TRAY INSIDE ONE OF THE CUPS (PREP BOWL). THE PARTICULATE WAS LIGHT BROWN IN COLOR AND APPROXIMATELY 1.25" LONG. VISUAL EXAMINATIONS WERE PERFORMED WITH UNAIDED EYES. ALTHOUGH THE CUSTOMER REPORT WAS CONFIRMED, IT IS NOT POSSIBLE TO CONCLUSIVELY RELATE THE COMPLAINT TO A MANUFACTURING NONCONFORMANCE AS THE PRODUCT PACKAGING WAS RECEIVED OPENED. THE SOURCE OF CONTAMINATION CANNOT BE DETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "HAIR CONTAMINATION WAS OBSERVED ON THE PREP BOWL BEFORE USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP CENTRAL VENOUS OXIMETRY SET PRESEP CATHETER DQE EDWARDS LIFESCIENCES, PR X3820HSJD 59278879

    Patients

    Seq Age Sex Outcome Treatment
    1