BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRY SYSTEM 3 CARTRIDGE FOR HEMODIALYSIS

    MDR report key: 13932 · Received April 7, 1994

    Report

    Report Number
    13932
    Event Type
    Malfunction
    Date Received
    April 7, 1994
    Date of Event
    March 23, 1994
    Report Date
    April 4, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIALYSIS MACHINE ALARMED INDICATING AIR IN BLOOD. RPTR CLAMPED LINES AND UNLOADED CARTRIDGE. AIR DETECTOR AND LINES WERE CLEANED AND CARTRIDGE RELOADED. CARTRIDGE CRACKED AND BLOOD SPRAYED. RPTR WAS UNABLE TO RETURN BLOOD SO AS NOT TO INSTILL AIR INTO PT. PT LOST APPROX 200 CC OF BLOOD. NO PROBLEMS NOTED WITH PT. THREE MORE EPISODES OCCURRED WHERE THE CARTRIDGE CRACKED. NO PT WAS INVOLVED. EVENTS HAPPENED WHILE PRIMING MACHINES. MFR'S QC AND SALES REP WERE NOTIFIED. PRODUCT WITH SAME LOT NUMBERS WERE PULLED FROM SHELF. ONE CRACKED CARTRIDGE WAS SENT TO CO FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRY SYSTEM 3 CARTRIDGE FOR HEMODIALYSIS CARTRIDGE FOR HEMODIALYSIS FII CGH MEDICAL, INC. 10Y15331, 11Y15345, 01Z15340

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other