BEUDAMED
    FDA Adverse Event Death Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 466806 · Received June 17, 2003

    Report

    Report Number
    1423500-2003-00590
    Event Type
    Death
    Date Received
    June 17, 2003
    Date of Event
    December 20, 2002
    Report Date
    May 22, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP LAW DEPT RECEIVED, VIA PLAINTIFFS' DISCOVERY REQUESTS, NOTIFICATION OF A PT DEATH. ACCORDING TO THIS DOCUMENT, THE VENOUS BLOODLINE BECAME DETACHED FROM THE PT'S PERMANENT CATHETER DURING DIALYSIS USING THE 1550 HEMODIALYSIS MACHINE. NO ADD'L INFO HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1550 HEMODIALYSIS MACHINE SPS 1550 FKP BAXTER HEALTHCARE CORP. 1550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death