BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIALYZER

    MDR report key: 66357 · Received February 4, 1997

    Report

    Report Number
    MW1010652
    Event Type
    Other
    Date Received
    February 4, 1997
    Date of Event
    January 17, 1997
    Report Date
    January 22, 1997
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FJI
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PLACED ON DIALYZER AS ORDERED. HAD BEEN ON ANOTHER UNIT WITHOUT PROBLEMS. THREE MINS INTO TREATMENT, PT C/O FLUSHED FACE, TINGLING SENSATION, ITCHING ARMS AND NECK AND TIGHTNESS IN CHEST. TREATMENT DISCONTINUED. BLOOD NOT RETURNED TO PT. GIVEN BENADRYL 50MG IVP AND SOLU-MEDROL 125 MG IVP. PT RESTARTED ON ANOTHER UNIT WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER DIALYZER FJI TERUMO MEDICAL CORP. T 220 8896 C11 4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other