BEUDAMED
    FDA Adverse Event Death Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 360611 · Received November 8, 2001

    Report

    Report Number
    1423500-2001-01612
    Event Type
    Death
    Date Received
    November 8, 2001
    Date of Event
    November 6, 2001
    Report Date
    November 7, 2001
    Manufacturer
    NISSHO CORPORATION
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ICU PT, WITH CONGESTIVE HEART FAILURE AND HYPERCALEMIA WAS BROUGHT TO THE IN-PATIENT DIALYSIS UNIT FOR A TWO HOUR DIALYSIS TREATMENT. THE PT APPEARED ANXIOUS PRIOR TO DIALYSIS, SO THE PHYSICIAN GAVE THE PT HALDOL (DOSE ADMINSTERED NOT PROVIDED). THE DIALYSIS TREATMENT WAS STARTED WITH A PRE-RINSED DIALYZER, WHEN THE PT VOMITTED. THE TREATMENT WAS TERMINATED. THIS PT WAS GIVEN 500CC OF SALINE AFTER VOMITTING. PT'S BLOOD PRESSURE WENT DOWN TO 74. THE PT EXPERIENCED CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49860 CT GAMMA DIALYZER (CT 190G) HOLLOW FIBER DIALYZER FJI NISSHO CORPORATION CT 190G A01F14X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death