BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BLOOD CARTRIDGE

    MDR report key: 10376 · Received December 6, 1993

    Report

    Report Number
    MW1000015
    Event Type
    Malfunction
    Date Received
    December 6, 1993
    Report Date
    December 3, 1993
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    WHEN THE PT WAS UNDERGOING HEMODIALYSIS, BLOOD LEAKED UNDER THE TUBING AT THE CLAMP. THE CLAMP HAS PROTRUSIONS ON IT WHICH PREVENTS A TIGHT SEAL AND ALLOWS AIR TO ENTER THE TUBING APPARATUS AND BLOOD TO LEAK FROM THE TUBING APPARATUS. THERE WERE NO PT COMPLICATIONS. ON THE SECOND PT, DURING A DIALYSIS PROCEDURE, THE BLOOD CARTRIDGE FILLED WITH MICRO-BUBBLES WHICH WERE INFUSED INTO THE PT. THE AIR AND BLOOD DETECTOR WAS ON, BUT IT DOES NOT REGISTER MICRO-BUBBLES, ONLY MACRO-BUBBLES. THE RN TOOK THE PT OFF THE MACHINE. THE PT COMPLAINED OF PAIN IN THE AREA OF THE CENTRAL LINE, RIGHT SUBCLAVIAN. THE PT RESUMED DIALYSIS WITH A NEW TUBING SET-UP. OTHER TUBING IN THE SAME LOT HAS PROTRUSIONS ON THE CLOSE-OFF CLAMP, WHICH PIERCES THE ACTUAL TUBING AND ALLOWS AIR TO INFILTRATE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE BLOOD CARTRIDGE CARTRIDGE USED WITH CENTRY SYSTEM III FJK CGH MEDICAL, INC. 08Y15310

    Patients

    Seq Age Sex Outcome Treatment
    1 *