BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO

    MDR report key: 17240 · Received January 10, 1994

    Report

    Report Number
    2243621-1993-00237
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    October 20, 1993
    Report Date
    November 22, 1993
    Manufacturer
    TERUMO CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES PT REACTION ONE HR INTO THE PT'S TREATMENT SHE COMPLAINED OF CHRUSHING CHEST PAIN. THE BLOOD IN THE MACHINE LOOKED LIGHT. THE TREATMENT WAS STOPPED AANAD THE BLOOD RETURNED TO PT. PT'S PRE HCT WAS 23 WWITH A POST HCT OF 16. THE PT IS A KNOWN JD BLEED. THE PT WAS ADMITTED TO HOSPITAL WITH GROSS HEMOLYSIS. THE MACHINE WAS PULLED AND FOUND TOBE WORKING CORRECTLY. NO CAUSE COULD BE FOUND FOR THE HEMOLYSIS SO THIS MDR IS BEING FILED ON THE DIALYZER. C121 3RD USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO HEMODIALYZER KDI TERUMO CORPORATION C0121 8893602

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention