BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURY SYSTEM BLOOD TUBING

    MDR report key: 15276 · Received January 10, 1994

    Report

    Report Number
    2243621-1993-00249
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    November 23, 1993
    Report Date
    December 6, 1993
    Manufacturer
    COBE GAMBRO HOSPAL
    Product Code
    FKY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT AFTER HEMODIALYSIS TREATMENT WAS INITATED AIR WAS DRAWN INTO EXTRACORPORSAL SYSTEM. SOURCE SITE APPEARED TO BE AT VENOUS END OF DIALYZER BLOODLINE CONNEECTING PIECE. EBL 200CC. TREATMENT WAS RESTARTED WITH NEW BLOODLINE WITHOUT FURTHER INCIDENT FACILITY NOT CERTAIN IF LEAK CAME FROM A CRACK IN THE DIALYZER OR LEUR END OF VENOUS BLOODLINE AS BOTH WERE DISCARDED. THIS WAS REPORTED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY SYSTEM BLOOD TUBING BLOODLINE (VENOUS) FKY COBE GAMBRO HOSPAL 018-440-500 0943326

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention