BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESEP - CENTRAL VENOUS OXIMETRY KIT

    MDR report key: 1832806 · Received September 13, 2010

    Report

    Report Number
    2015691-2010-14048
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K060093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED AT HOSPITAL. THE LOT NUMBER WAS NOT PROVIDED AND WE ARE UNABLE TO COMPLETE A DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR HAD SOME DIFFICULTIES WITH REMOVING THE GUIDEWIRE. THERE WAS NO PROBLEM WITH GUIDEWIRE INSERTION BUT WHEN THE PHYSICIAN WENT TO REMOVE THE GUIDEWIRE, IT GOT CAUGHT APPROXIMATELY 4 INCHES FROM THE BOTTOM AND HAD UNRAVELED. THIS OCCURRED AFTER THE DILATOR AND CATHETER WERE INSERTED, WHEN TRYING TO REMOVE THE GUIDEWIRE OUT OF THE CATHETER, THE GUIDEWIRE STARTED TO UNRAVEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP - CENTRAL VENOUS OXIMETRY KIT CENTRAL VENOUS CATHETER DQE EDWARDS LIFESCIENCES, PR XA3820HKCDC

    Patients

    Seq Age Sex Outcome Treatment
    1