BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI 9

    MDR report key: 403254 · Received July 3, 2002

    Report

    Report Number
    1823260-2002-00209
    Event Type
    Injury
    Date Received
    July 3, 2002
    Date of Event
    June 14, 2002
    Report Date
    June 14, 2002
    Manufacturer
    AVL GMBH
    Product Code
    CEM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IN 2002 AT 16:34 PATIENT SAMPLE RUN ON SUSPECT DEVICE AND K+ (POTASSIUM) MEASURED 5.0 MMOL/L. THE FOLLOWING DAY AT 00:29 ANOTHER SAMPLE RAN ON SUSPECT DEVICE AND K+ (POTASSIUM) WAS 9.9 MMOL/L. PATIENT TREATED WITH KAYEXALATE 500 MG. THE SAME DAY AT 5:00 PATIENT SAMPLE RAN ON ANOTHER DEVICE AND 5.7 MMOL/L. PHYSICIAN DISCONTINUED TREATMENT. THE PATIENT WAS TAKEN OFF OF LIFE SUPPORT AND LATER EXPIRED FROM ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI 9 MODULAR CRITICAL CARE ANALYZER CEM AVL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention