BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO CORPORATION

    MDR report key: 15896 · Received March 28, 1994

    Report

    Report Number
    2243621-1994-05053
    Event Type
    Injury
    Date Received
    March 28, 1994
    Date of Event
    January 26, 1994
    Report Date
    March 9, 1994
    Manufacturer
    TERUMO CORPORATION
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT STATED HE DID NOT FEEL WELL PRE TREATMENT. 3-1/2 HRS INTO HIS TREATMENT HE COMPLAINED OF CHILLS. HIS PRE TEMP. WAS 96.8 WITH A MAXIMUM TEMP OF 101.4. THE PHYSICIAN WAS NOTIFIED AND PYROGEN TESTING AND BLOOD CULTURES ORDERED. VANCOMYCIN 1 GM WAS GIVEN IV. THE TREATMENT WAS DISCONTINUED 1 HR AND 20 MINUTESS EARLY. THE PT WAS LITHARGIC AND UNABLE TO STAND ON OWN POST TREATMENT.. HE WAS SENT TO THE HOSPITAL. PYROGEN TESTING AND BLOOD CULTURES WERE NEGATIVE. THE PT HAS SINCE DIALYZED AT THE FACILITY WITHOUT DIFFICULTY. TAF 175 USE #10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CORPORATION HOLLOWW FIBER HEMODIALYZER FJI TERUMO CORPORATION TAF 175 8893622

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention BAXTER 550 DIALYSIS MACHINE