BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMC ARTERIAL BLOODLINE

    MDR report key: 268914 · Received March 9, 2000

    Report

    Report Number
    268914
    Event Type
    Injury
    Date Received
    March 9, 2000
    Date of Event
    December 6, 1999
    Report Date
    February 9, 2000
    Manufacturer
    FMC USA
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    KINK NOTED AT DISTAL ARTERIAL BLOODLINE PUMP SEGMENT AT RINSE BACK BY "DPCT". RINSE BACK NOT COMPLETED. BLOOD SAMPLE OBTAINED. SERUM "CHERRY RED" IN COLOR. HCT 32.5%. VITAL SIGNS= B/P 190/100, PULSE REGULAR AT 80. PT DENIES CHEST PAIN OR SHORTNESS OF BREATH. PT COMPLAINS OF "FLU LIKE" SYMPTOMS. APPROX 10:40PM DR NOTIFIED WITH ORDERS RECEIVED TO DIALYZE PT FURTHER OR TRANSPORT TO ER. APPROX 10:45 PM PT COMPLAINS OF "CHEST TIGHTNESS". PT TRANSPORTED TO ER PER EMS. B/P 170/90, PULSE 80 & REGULAR AT TIME OF TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMC ARTERIAL BLOODLINE HEMODIALYSIS BLOOD LINE FII FMC USA * (2)

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization FRESENIUS 2008E HEMODIALYSIS DELIVERY SYSTEM.