BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIDIAN HEMODIALYSIS MACHINE-REFURB

    MDR report key: 424264 · Received October 23, 2002

    Report

    Report Number
    1423500-2002-01354
    Event Type
    Death
    Date Received
    October 23, 2002
    Date of Event
    September 12, 2002
    Report Date
    September 25, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 25, 2002, BAXTER HEALTHCARE CORP WAS NOTIFIED OF THIS EVENT THAT OCCURRED IN 2002. FACILITY BIOMEDICAL TECHNICIAN CALLED TO REQUEST THIS MERIDIAN DEVICE BE EVALUATED BY BAXTER FOLLOWING A PT EVENT TWO WEEKS AGO. FACILITY CONTINUED TO USE THE DEVICE DURING THIS TIME. PT WAS RECEIVING HEMODIALYSIS ON THIS MERIDIAN DEVICE WHEN THE PT CODED. "PHYSICIAN ALERTED STAFF TO THIS PT'S TERMINAL MEDICAL CONDITION WHEN TAKEN ON AS A PT". DO NOT RESUSCITATE (DNR) WAS IN EFFECT AT THE TIME. PT DECEASED ACCORDING TO BIO-MIDICAL TECHNICIAN, ALTHOUGH THERE WAS NO OFFICIAL REPORT FROM HOSP. NO BLOOD OR DIALYSATE SAMPLES WERE DRAWN AT THE TIME OF THIS EVENT. NO FURTHER INFO HAS BEEN PROVIDED BY THE HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIDIAN HEMODIALYSIS MACHINE-REFURB MERIDIAN KDI BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death