BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPAL

    MDR report key: 14673 · Received February 25, 1994

    Report

    Report Number
    2243621-1994-05013
    Event Type
    Injury
    Date Received
    February 25, 1994
    Date of Event
    January 13, 1994
    Report Date
    January 26, 1994
    Manufacturer
    CGH
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD NO COMPLAINTS PRE DIALYSIS. BLOOD PRESSURE 140/80. TEMPERATURE 96 PULSE 80. DIALYZEEEER WAS INITIATED IN THE USUAL MANNER. PT REPORTED "FEELING BAD" AS SOON AS DIALYSIS WAS INITIATED. PT COMPLAINED OF PALPATATIONS, DIFFICULTY TALKING, NUMBNESS IN THROAT AND TONGUE AND FEELING SWOLEN. DIALYSIS TERMINATED, PULSE 120 BP=130/P. PT BEGAN TO FEEL WORSE AND MORE SHORTNESS OF BREATH. AMBULANCE WAS CALLED. PT WAS PLACED ON MONIITOR AND GIVEN SOLU-CORTEF 100MG IV. THE PT WAS TRANSPORTED TO THE HOSPITAL WITH 02 BY MASK AND ADMITTED AFTER ARRIVAL THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPAL DIALYZER KDI CGH AN69-12 93F17-37

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| O FRESENIUS 2008U| NMC BLOODLINES-LOTNO, MODNO UNKNOWN