BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD TUBING

    MDR report key: 20116 · Received March 3, 1995

    Report

    Report Number
    MW1005310
    Event Type
    Injury
    Date Received
    March 3, 1995
    Date of Event
    February 25, 1995
    Report Date
    March 1, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIATED CHRONIC HEMODIALYSIS TREATMENT VIA RIGHT JUGULAR DIALYSIS CATHETER. TWO TO FOUR MINUTES POST INITIATION OF TREATMENT, NOTED VENOUS BLOOD LINE DISCONNECTED FROM VENOUS PORT OF DIALYSIS CATHETER. PT SEEN IN RESPIRATORY DISTRESS WHICH SUBSEQUENTLY PROGRESSED TO CARDIO-PULMONARY ARREST. EFFORTS TO RESUSCITATE SUCCESSFUL. TRANSFERRED TO HOSP, ADMITTED TO ICU AND PLACED ON VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD TUBING BLOOD TUBING FJK COBE RENAL CARE, INC. 02A-15332

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L