BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPAL HEMOSPAL FILTER

    MDR report key: 18699 · Received November 8, 1994

    Report

    Report Number
    18699
    Event Type
    Malfunction
    Date Received
    November 8, 1994
    Date of Event
    August 6, 1994
    Report Date
    October 5, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED 7/5/94 AFTER MOTOR CYCLE ACCIDENT, HAD JEJUNAL PERFORATION, SEPSIS, ARDS. WAS ON CONTINUOUS VENO-VENOUS HEMODIALYSIS. AFTER FILTER AND TUBING WERE CHANGED ON 8/6 @ 1400, VENOUS PRESSURE ON SYSTEM WAS DECREASED TO 20-30 TORR. BLOOD LEAK WAS NOTED AT THE FILTER HEADER AT 1700. POSSIBILITY LEAK WAS DUE TO AN "AIR LOCK" FROM PRIMING THE NEW FILTER; HOWEVER THE INSTITUTION HAS HAD 5 LEAKS FROM THE SAME AREA OF THE FILTER AND UNDER DIFFERENT CIRCUMSTANCES. NO TRANSFUSIONS REQUIRED. FILTER AND SYSTEM CHANGED AT 2300.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPAL HEMOSPAL FILTER DIALYSIS FILTER FII CGH MEDICAL, INC. AN69 93G2010

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IVAC INFUSION PUMP| HOSPAL BM 22 CVVHD DIALYSIS PUMP| PB 2000 VENTILATOR