BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT

    MDR report key: 1823106 · Received September 1, 2010

    Report

    Report Number
    2015691-2010-13992
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 26, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRIPLE LUMEN 7F 20 CENTIMETER PRESEP CATHETER AND 1 - 0.032" GUIDEWIRE WERE RETURNED. THE GUIDEWIRE WAS RECEIVED REMOVED FROM THE CATHETER. THE GUIDEWIRE HAD A BROKEN WELD ON THE STRAIGHT TIP END AND THE OUTER COIL WIRE HAD BEEN UNCOILED OVER A 15 CENTIMETER AREA. THERE WERE NO SECTIONS OF THE WIRE MISSING. THE CATHETER APPEARED TO BE IN GOOD CONDITION, THERE WERE NO KINKS OR PUNCTURES. THE DISTAL LUMEN WAS FOUND TO HAVE A FULL OCCLUSION NEAR THE TIP OF THE CATHETER. THE OCCLUSION WAS CLEARED AND FOUND TO BE DRIED BLOOD. A LAB SAMPLE 0.032" GUIDEWIRE WAS PASSED TIP TO HUB AND HUB TO TIP SMOOTHLY, WITH NO RESTRICTIONS. THE LOT NUMBER WAS NOT PROVIDED AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR WAS ATTEMPTING TO INSERT THE CATHETER, THE GUIDEWIRE WAS CAUGHT IN THE INTERNAL LUMEN OF THE CENTRAL LINE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT CENTRAL VENOUS OXIMETRY CATHETER DQE EDWARDS LIFESCIENCES, PR X3820HS

    Patients

    Seq Age Sex Outcome Treatment
    1