BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDIA 6N DIALYSER

    MDR report key: 25238 · Received January 18, 1995

    Report

    Report Number
    25238
    Event Type
    Injury
    Date Received
    January 18, 1995
    Date of Event
    August 19, 1994
    Report Date
    August 31, 1994
    Manufacturer
    CGH MEDICAL
    Product Code
    KOC
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HEMODIALYSIS THE FILTER LOCATED INSIDE THE DIALYSER BROKE CAUSING THE MIXING OF THE PATIENT'S BLOOD WITH THE ACID BATH FLUID. THE BLOOD (200CC IN DIALYSER, 150CC IN TUBING) WAS NOT RETURNED TO THE PATIENT. THE DIALYSER WAS REPLACED AND HEMODIALYSIS CONTINUED WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUNDIA 6N DIALYSER HEMODIALYSIS KOC CGH MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention