BEUDAMED
    FDA Adverse Event Death Summary report: N

    NMC VENOUS LINE

    MDR report key: 111771 · Received August 7, 1997

    Report

    Report Number
    111771
    Event Type
    Death
    Date Received
    August 7, 1997
    Date of Event
    August 2, 1997
    Report Date
    August 7, 1997
    Manufacturer
    FMC NORTH AMERICA
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    0605-PT INITIATED HEMODIALYSIS WITH A SECURE CONNECTION OF DIALYSIS LINES TO PT'S ACCESS WHICH WAS A SUBCLAVIAN CATHETER. 0630-PT CARE TECHNICIAN RESPONDED TO A VENOUS ALARM CONDITION ON MACHINE #11. UPON ARRIVAL TO MACHINE, PCT NOTED A VENOUS LINE DISCONNECTION FROM THE SUBCLAVIAN CATHETER, WITHOUT STOPPAGE OF THE MACHINE BLOOD PUMP. BLOOD PUMP MANUALLY TURNED OFF AND VENOUS LINE CLAMPED, EVENT RESULTED IN AN APPROXIMATE 250CC BLOOD LOSS. PT BECAME LETHARGIC WITH BP 74/46, BLOOD RETURNED WITH AN EXTRA 1000 CC NSS INFUSED. PT BECAME UNRESPONSIVE AND ARRESTED. CPR INITIATED 911 CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NMC VENOUS LINE VENOUS LINE-DEVICE #1 FJK FMC NORTH AMERICA 03-7317-5 UNK
    2 FRESENIUS 2008H DIALYSIS MACHINE DEVICE #2 FII FRESENIUS USA 2008H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| L ARTIFICIAL DIALYZER| FRESENIUS DIALYSIS MACHINE| ARTERIAL LINE| SUBCLAVIAN CATHETER