BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASPLIT LONG TERM DIALYSIS CATHETER

    MDR report key: 12202485 · Received July 15, 2021

    Report

    Report Number
    12202485
    Event Type
    Death
    Date Received
    July 15, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON DICKINSON AND COMPANY (BD)
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PT ATTENDED REGULARLY SCHEDULED HEMODIALYSIS TREATMENT ON (B)(6) 2021. TREATMENT WAS INITIATED AT 0620. AT 0800, THE DIALYSIS MACHINE ALARMED. WHILE RESPONDING TO THE ALARM, IT WAS NOTED THE PT WAS UNRESPONSIVE. VENOUS HUB OF CATHETER NOTED TO BE DISCONNECTED FROM THE LUMEN OF THE CATHETER. HEMACLIP TO BLOODLINES REMAINED IN PLACE. BLOOD LOSS FROM DISCONNECTION NOTED. VENOUS LINE OF CATHETER CLAMPED. FLUID BOLUS OF 500CC GIVEN THROUGH ARTERIAL LIMB. PT NOTED TO BE PULSELESS, CPR STARTED. AED APPLIED AND ADVISED NO SHOCK X2; 911 CALLED. EMS ARRIVED AND ASSUMED CARE OF PATIENT, SPONTANEOUS CIRCULATION RETURNED. PT TRANSFERRED TO ED AT (B)(6) MEDICAL CENTER WHERE HE AGAIN BECAME PULSELESS. RESUSCITATIVE MEASURES ENSUED, HOWEVER, WERE UNSUCCESSFUL. TIME OF DEATH CALLED AT 1010 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074669 HEMASPLIT LONG TERM DIALYSIS CATHETER DIALYSIS CATHETER MSD BECTON DICKINSON AND COMPANY (BD) REAT1500

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H 180NRE OPTIFLUX DIALYZER| COMBISET BLOOD LINES | FRESENIUS PRODUCTS: 2008T MACHINE| GRANUFLO 2.0K, 2.5CA, 1.0MG, 100DEXTROSE| HEMACLIP | NATURALYTE SERIES 4000| NORMAL SALINE 1000ML | TRUE FLOW