BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER

    MDR report key: 11788 · Received March 1, 1994

    Report

    Report Number
    MW1000907
    Event Type
    Malfunction
    Date Received
    March 1, 1994
    Date of Event
    January 26, 1994
    Report Date
    January 26, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SECOND ATTEMPT WAS MADE TO DIALYZE THE PT IN THE MICU. (SEE 1000906 FOR FIRST INCIDENT.) DUE TO THE POSSIBILITY THAT A DIALYZER SENSITIVITY WAS THE CAUSE OF THE PREVIOUS RESPIRATORY DISTRESS SYNDROME, A PAN (POLYACRILONITRIL) DIALYZER WAS SET UP; THE DIALYZER WAS HYPERRINSED WITH 3 LITERS OF NORMAL SALINE. PT HAD BEEN EXTUBATED IN THE MORNING. RESPIRATIONS STILL APPEARED SOMEWHAT LABORED WITH PT USING ACCESSORY CHEST MUSCLES FOR BREATHING, BILATERAL RALES HEARD BUT WITH AIR MOVEMENT AND PT APPEARED COMFORTABLE. DIALYSIS WAS INITIATED AND APPROX 15 MINS AFTER INITIATION OF TREATMENT, THE PT BECAME RESTLESS, BREATHING BECAME VERY LABORED AND OXYGEN SATURATION DROPPED TO 80%. TREATMENT WAS DISCONTINUED, BLOOD WAS NOT RETURNED. BENADRYL, EPINEPHRINE, SOLUMEDROL GIVEN. ICU TEAM CALLED AND PT REINTUBATED. PT CONSCIOUS. (ALSO SEE 1000905 AND 1000906.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER FJI CGH MEDICAL, INC. FILTRAL 12 9130905

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR