BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 297445 · Received September 22, 2000

    Report

    Report Number
    8030665-2000-00274
    Event Type
    Death
    Date Received
    September 22, 2000
    Date of Event
    August 26, 2000
    Report Date
    August 29, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED ONE HOUR AND TWENTY MINUTES INTO THE TREATMENT, THE MACHINE ALARMED FOR LOW VENOUS PRESSURE. THE VENOUS LINE HAD BECOME SEPARATED FROM THE ASHSPLIT CATHETER (IMPLANTED 6 MONTHS AGO). ESTIMATED BLOOD LOSS 2000CC. THE PT WAS PLACED IN TRENDELENBURG POSITION AND GIVEN 500CC OF SALINE. CPR WAS ADMINISTERED WITH POSITIVE RESULTS. THE PT WAS TRANSPORTED TO THE HOSP. THE PT SUBSEQUENTLY EXPIRED IN THE ER. THE SAMPLE WAS DISCARDED BY THE USER. MEDWATCH FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC HEMODIALYSIS BLOOD LINE FKJ ERIKA DE REYNOSA NA 0ER209

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H 08/26/2000| BAXTER 550 DIALYSIS MACHINE, ASHSPLIT CATHETER