BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSA F8 (HF/PS/1.8/M)

    MDR report key: 36320 · Received August 26, 1996

    Report

    Report Number
    54354-1996-00265
    Event Type
    Injury
    Date Received
    August 26, 1996
    Date of Event
    August 21, 1996
    Report Date
    August 22, 1996
    Manufacturer
    FUSA
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN, DON REPORTED THAT DIALYSIS WAS INITIATED WITHOUT INCIDENT. APPROX. 20 MINUTES INTO TREATMENT THE PT COMPLAINED OF FEELING HOT, PT WAS AFEBRILE, BP 220/143. BLOOD CULTURES/2 WERE DONE. BENADRYL 25MG IV GIVEN. CXR AND EKG WERE OBTAINED. PT COMPLAINED OF FEELING WORSE; SOB, DIAPHORETIC, LISTLESS. THE TREATMENT WAS STOPPED AND THE PT'S BLOOD WAS NOT RETURNED. EBL>200CC. CULTURES OF ALL PRODUCTS USED WERE DONE. MD WANTED THE DIALYZER TESTED. SAMPLE ENVELOPE SENT TO THE FACILITY ON 8/22/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSA F8 (HF/PS/1.8/M) DIALYZER KDI FUSA * 6C00908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention