BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO C121 (HF/CR 1.2L)

    MDR report key: 20500 · Received December 21, 1994

    Report

    Report Number
    2243621-1994-05340
    Event Type
    Other
    Date Received
    December 21, 1994
    Date of Event
    November 3, 1994
    Report Date
    November 18, 1994
    Manufacturer
    TERUMO
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT OFFERED NO COMPLAINTS PRE-TREATMENT. FIVE MINUTES INTO THE TREATMENT SHE COMPLAINED OF NECK AND BACK PAIN AND VIOLENT SHAKINGS WITH MO TEMPERATURE CHANGE. PRE-TEMP. 95.6 F. BLOOD PRESSURE UP 220/110. THE TREATMENT WAS DISCONTINUED AND HER BLOOD WAS RETURNED. 50MG BENADRYL IV WAS GIVEN. AFTER TWENTY MINUTES THE TREATMENT WAS RESTARTED ON A PRE-PROCESSED BIO-ALLERGO. SHE HAD NO FURTHER PROBLEMS. THE FIRST DIALYZER WAS A C121 USE #1. THIS MDR IS BEING FILED THE DIALYZER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO C121 (HF/CR 1.2L) HOLLOW FIBER HEMODIALYZER FJI TERUMO C121 8894 C 30

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other COBE CENTRY SYSTEM 2