BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMODIALYSIS TUBING SET

    MDR report key: 889111 · Received August 1, 2007

    Report

    Report Number
    889111
    Event Type
    Death
    Date Received
    August 1, 2007
    Date of Event
    June 4, 2007
    Report Date
    June 6, 2007
    Manufacturer
    FRESENIUS MEDICAL CARE, N.A
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNEXPLAINED DISCONNECTION OF HEMODIALYSIS BLOOD TUBING SET @ VENOUS LINE LUER CONNECTOR. PATIENT HAD BEEN UNDERGOING HEMODIALYSIS FOR APPOX 2.5 HOURS OF A 3 HOUR PLANNED TREATMENT. RESULTS OF POST MORTUM EXAM COMPLETED IN 2007 INDICATE CAUSE OF DEATH AS PULMONARY EMBOLISM. I THOUGHT THIS HAD BEEN SUBMITTED ON FOUR DAYS LATER, UNTIL NOTICED SIXTEEN DAYS LATER WHEN UPDATED. SUBMITTED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS TUBING SET HEMODIALYSIS TUBING SET FKJ FRESENIUS MEDICAL CARE, N.A * 7CR368

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death CATHETER - UNK PRODUCT| BICARBONATE: FRESENIUS| DIALYSATE ACID| DIALYZER: FRESENIUS MCNA