BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMO-SAFE

    MDR report key: 4272870 · Received October 31, 2014

    Report

    Report Number
    4272870
    Event Type
    Death
    Date Received
    October 31, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 24, 2014
    Manufacturer
    FRESENIUS NORTH AMERICA
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS WAS THE PT'S 6TH HEMODIALYSIS TREATMENT. HIS FIRST AFTER BEING TRANSFERRED FROM ICU. TREATMENT WAS INITIATED BY CANNULATION X 2. MD WAS CALLED SEVERAL TIMES TO COME AND SEE THE PT WHILE HE WAS ON TREATMENT. UNABLE TO SUSTAIN AN ADEQUATE BLOOD FLOW WITH NEW FISTULA. PER MD ORDER, CATHETER WAS ACCESSED AND BLOOD LINES TRANSFERRED TO CATHETER. RN STAYED WITH PT FOR 10 MINUTES AFTER ACCESS WAS CHANGED. BLOOD PRESSURE AND VS WERE STABLE. RN ASSESSED HER SECOND PT IN THE SUITE, WHEN SHE RETURNED TO THIS PT AT 12:33PM; SHE NOTICED BLOOD ON HIS GOWN AND BESIDE HIM IN THE BED. SHE STOPPED THE BLOOD PUMP AND THEN ATTEMPTED TO RE-SECURE THE VENOUS BLOOD LINE, AT THAT TIME THE SYSTEM SEPARATED AND SHE QUICKLY RE-SECURED THE VENOUS LINE; HEMO-SAFE DEVICE WAS STILL ATTACHED AS PER PROTOCOL. SHE THEN WENT AROUND THE BED TO THE MACHINE TO ADMINISTER SALINE FOR POTENTIAL VOLUME DEPLETION. DURING BOLUS, THE PT'S HEART RATE WAS NOTED TO BE DROPPING FROM THE MID 60'S QUICKLY TO THE 50'S AND AT LAST CHECK WAS 46. CODE BLUE BUTTON WAS PUSHED AND CRASH CART WAS BROUGHT INTO ROOM. PT BLOOD WAS RETURNED PRIOR TO THE CODE TEAM ARRIVAL. MD NOTIFIED. TEAM ARRIVED. HEARTRATE BETWEEN 40'S AND 50'S MEDICATIONS ADMINISTERED AND PADS APPLIED. DECISION TO CALL THE CODE WAS MADE BY MD AT 12:55PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698160 HEMO-SAFE HEMOSAFE FJK FRESENIUS NORTH AMERICA NA 14DRO0600081

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death