BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA DIALYZER

    MDR report key: 29030 · Received December 21, 1995

    Report

    Report Number
    MW1007975
    Event Type
    Injury
    Date Received
    December 21, 1995
    Date of Event
    December 15, 1995
    Report Date
    December 19, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FJG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS WAS THE 2ND DIALYSIS TREATMENT FOR THIS PT. THE FIRST TREATMENT WAS UNEVENTFUL ON THE SAME MODEL DIALYZER. THIRTY MINUTES INTO THE SECOND TREATMENT THE PT C/O SHORTNESS OF BREATH BECAME HYPOTENSIVE. DIALYSIS WAS STOPPED AND BLOOD NOT RETURNED AT THIS TIME. THE PT HAD WHEEZING ON AUSCULATION. HE WAS NOT WHEEZING PRE-DIALYSIS. THE PT WAS TREATED WITH EPINEPHRINE 0.9 MG IV PUSH, BENADRYL 50 MG IV, SOLUMEDROL 125 MG/IV PUSH. ONE HR LATER, DIALYSIS WAS RESTARTED ON A GAMMA STERILIZED PMMA DIALYZER WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA DIALYZER DIALYZER FJG COBE RENAL CARE, INC. A-700

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention