BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 91936 · Received May 14, 1997

    Report

    Report Number
    91936
    Event Type
    Death
    Date Received
    May 14, 1997
    Date of Event
    May 6, 1997
    Report Date
    May 9, 1997
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LFK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED IN THE ER WITH FACIAL INJURIES SUSTAINED IN A MOTORVEHICLE ACCIDENT. PT HAD HISTORY OF DIALYSIS AND END-STAGE RENAL DISEASE. PT WAS CATHETERIZED (LEFT FEMORAL VEIN) AND THIS WAS USED TO INFUSE VOLUMES OF BLOOD AND FLUIDS, TO WHICH THE PT RESPONDED POSITIVELY. PT WAS TRANSFERRED TO ICU. PT BECAME UNSTABLE AND DEVELOPED A SWOLLEN ABDOMEN. PT WAS TAKEN TO THE OR. UPON OPENING THE PT IT WAS DISCOVERED THAT THE CATHETER HAD PERFORATED THE LEFT FEMORAL VEIN. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant TRIPLE LUMEN (FEMORAL) CATHETER LFK ARROW INTL., INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death