BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDIA K 5N

    MDR report key: 10876 · Received October 14, 1993

    Report

    Report Number
    2243621-1993-00123
    Event Type
    Injury
    Date Received
    October 14, 1993
    Report Date
    September 3, 1993
    Manufacturer
    CGH
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNIT ALLEGES BLOOD LEAK. REPORTEDLY OCCURRED 40 MINUTES INTO DIALYSIS - FRANK BLOOD NOTED. TREAMENT STOPPED; RESTARTED WITH NEW DIALYZER. NO FURTHER MEDICAL INTERVENTION REQUIRED. PATIENT COMPLETED TREATMENT WITH NO FURTHER PROBLEMS. ESTIMATED BLOOD LOSS 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUNDIA K 5N PLATE DIALYZER KDI CGH ICSN SN 30517N11

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention