BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTIFICIAL KIDNEY

    MDR report key: 32102 · Received April 18, 1996

    Report

    Report Number
    32102
    Event Type
    Death
    Date Received
    April 18, 1996
    Date of Event
    April 8, 1996
    Report Date
    April 17, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROX 2 1/2 HRS INTO HEMODIALYSIS TREATMENT, PT BECAME UNRESPONSIVE. PLACED IN TRENDELENBURG POSITION AND 0.9% SALINE ADMINISTERED WITH SPONTANEOUS RETURN OF PULSE AND RESPIRATIONS. PT HAD JUST PREVIOUSLY BEEN TAKEN OFF DIALYSIS TO GO TO BATHROOM. SHE THEN RETURNED AND TREATMENT WAS RESUMED. PT WAS TRANSFERRED TO HOSP. HEMOLYSIS WAS IDENTIFIED AT THE HOSP. HCT WAS 19.2 ON 4/9 FROM 29.3 ON 3/20. AMYLASE WAS 347. PT WAS TAKEN TO SURGERY FOR REMOVAL OF GALLBLADDER. PT EXPIRED ON 4/9/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL KIDNEY ARTIFICIAL KIDNEY FJI TERUMO MEDICAL CORP. T220 8895K28A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death