BEUDAMED
    FDA Adverse Event Death Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 382592 · Received March 14, 2002

    Report

    Report Number
    1423500-2002-00340
    Event Type
    Death
    Date Received
    March 14, 2002
    Date of Event
    January 1, 1999
    Report Date
    January 13, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ATTORNEY REPORTED A PATIENT WAS BEING TREATED ON A 1550 HEMODIALYSIS DEVICE FOR AN ASPIRIN AND ALCOHOL OVERDOSE. DURING THE TREATMENT THE DEVICE GAVE A WATER PRESSURE ALARM AND THE TREATMENT WAS SUSPENDED FOR APPROXIMATELY ONE HOUR DUE TO WATER SYSTEM PROBLEMS IN THE FACILITY. TREATMENT RESUMED AND THE PATIENT WENT INTO RESPIRATORY ARREST. THE PATIENT WAS EXTUBATED. THE PATIENT SUBSEQUENTLY DIED. IT WAS REPORTED THAT THE PATIENT WAS NOT ATTRIBUTED TO THE DEVICE. NO OTHER INFORMATION IS KNOWN.

    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 50 YR Death