BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPS550

    MDR report key: 39150 · Received September 19, 1996

    Report

    Report Number
    1423500-1996-00002
    Event Type
    Death
    Date Received
    September 19, 1996
    Date of Event
    August 21, 1996
    Report Date
    September 19, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CENTER REPORTED 3.45 HRS INTO THE HEMODIALYSIS TREATMENT THE PT GASPED. A CARDIAC MONITOR SHOWED VENTRICULAR FIBRILLATION AND PT THEN ARRESTED. THE MD WAS PRESENT IN THE UNIT AT THE TIME OF THE INCIDENT AND PRONOUNCED THE PT DEAD IN THE UNIT. NO DEVICE ALARMS NOTED AT OR PRIOR TO THE INCIDENT. CAUSE OF DEATH IS REPORTED AS: CARDIAC ARREST. PER DIR OF NURSING, THE PT WAS USING A 0 K+ CONCENTRATE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPS550 HEMODIALYSIS SINGLE PATIENT SYSTEM FKP BAXTER HEALTHCARE CORP. 550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death