BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDEPATH LONG TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET

    MDR report key: 13678012 · Received March 3, 2022

    Report

    Report Number
    13678012
    Event Type
    Death
    Date Received
    March 3, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 2, 2022
    Manufacturer
    BD
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT ARRIVED FOR REGULARLY SCHEDULED HEMODIALYSIS TREATMENT. PRE TREATMENT VITAL SIGNS: BP 151/73, PULSE 69, RESP 18 TEMP 96.6. AT APPROX 0818 HEMODIALYSIS TREATMENT WAS INITIATED USING THE HEMODIALYSIS CENTRAL VENOUS CATHETER AT A PRESCRIBED BLOOD FLOW RATE OF 400 WITH A HEMOCLIP SECURING THE CONNECTION BETWEEN THE EVE AND VENOUS BLOODLINE. WITHIN FIRST SEVERAL MINUTES OF TREATMENT INITIATION THE RN DISCOVERED A POOL OF BLOOD OF APPROXIMATELY 100-300ML UNDER PATIENTS CHAIR. BLOOD PUMP WAS STOPPED BY RN, BLOOD LOSS WAS ORIGINATING FROM VENOUS BLOODLINE/VENOUS LUMEN CONNECTION SITE. CAROTID PULSE WAS PALPABLE, HEMODIALYSIS TREATMENT WAS TERMINATED, BLOOD WAS RETURNED USING ARTERIAL LUMEN OF CVC; 0827 PT BECAME UNRESPONSIVE, EMS CALLED, CPR INITIATED; 0834 PER AUTOMATED CUFF ON HEMODIALYSIS MACHINE: BP 110/17 PULSE 94. EMS ARRIVED AT 0840 AND ASSUMED CARE OF PATIENT. EMS CONTINUED RESUSCITATIVE EFFORTS WHILE TRANSPORTING PT TO HOSPITAL. ER REPRESENTATIVE INFORMED FACILITY CLINICAL MANAGER VIA TELEPHONE THAT PT EXPIRED AT 0920.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963436 GLIDEPATH LONG TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET HEMODIALYSIS CENTRAL VENOUS CATHETER MSD BD 5393230 REDX3944

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Death 180 NRE OPTIFLUX DIALYZER | COMBISET BLOOD LINES| FRESENIUS PRODUCT: 2008T MACHINE| GRANUFLO 2.0K 2.5 CA 1.0MG 1000DEXTROSE| HEMACLIP