BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 49493 · Received November 19, 1996

    Report

    Report Number
    1713683-1996-00190
    Event Type
    Injury
    Date Received
    November 19, 1996
    Date of Event
    October 2, 1996
    Report Date
    November 19, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE DOES NOT INDICATE THAT THIS HAS BEE A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO FIELD. A SECONDARY SEARCH OF DTF HISTORY FOR THIS PRODUCTION LOT IS NOT POSSIBLE WITHOUT RETURNED PART. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: AFFECTED COMPONENT, PRV-3, WAS REPLACED AND DISCARDED BY TECH, AFFTECTED COMPONENT WAS NOT RETURNED FOR EVAL AND WITHOUT AFFECTED COMPONENT, A THOROUGH EVAL CANNOT TAKE PLACE. ALTHOUGH COMPONENT WAS NOT RETURNED, SEVERAL CONCLUSIONS AS TO REPORTED INCIDENT CAN BE MADE FORM INFO FORWARDED FROM FACILITY. 1. AS REPORTED IN ATTACHED FAXES FROM FACILITY, DIAPHRAGM INSIDE OF PRV-3 WAS RED. CURRENT DIAPHRAGM IS OF A SANTOPRENE SUBSTANCE AND IS IVORY IN COLOR. THIS INDICATES THAT MACHINE HAS NOT RECIEVED AN ENTIRE OR CORRECT PREVENTIVE MAINTENANCE IN AT LEAST TWO YEARS, AS THAT IS TIME FRAME THAT NEW DIAPHRAGM HAS BEEN IN USE. NEW DIAPHRAGM WAS PUT INTO USE ON ECO#62860 IN 5/94. ALL SPARES KITS AND PM KITS SINCE THAT TIME PERIOD HAVE INCLUDED NEW DIAPHRAGMS FOR USE. IT HAD BEEN OBSERVED THAT RED DIAPHRAGMS WERE SUSCEPTIBLE TO DEGRADATION. USE OF SANTOPRENE DIAPHRAGM AND A REGULAR PM SCHEDULE TO CHANGE DIAPHRAGM IS DESIGNED TO PREVENT THIS TYPE OF PROBLEM. FACILITY COMMUNICATED THAT MACHINE WAS LEAKING. DUE TO DIFFICULTY IN COMMUNICATING WITH CUSTOMER, IT COULD NOT BE DETERMINED EXACTLY WHERE MACHINE WAS LEAKING FROM, BUT A LEAK FROM ULTRAFILTRATION SYSTEM IS CONSISTENT WITH EXCESS WEIGHT REMOVAL. IT HAS ALSO BEEN SEEN PREVIOUSLY THAT WHEN PRV-3 DIAPHRAGM DEGRADES, AN EXTERNAL LEAK DEVELOPS. SO IT CAN BE ASSUMED THAT LEAK WAS FROM ULTRAFILTRATION SYSTEM. TO HELP VERIFY ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED BEFORE FIRST TREATMENT DAY, IF MACHINE HAS BEEN TURNED OFF, IT A PT WEIGHT DISCREPANCY IS DISCOVERED, IF DIALYSATE TYPE IS CHANGED (BICARBONATE OR ACETATE), OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10)0 OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF CALCUALTED VALUE TO ACTUAL VALUE AFTER TREATMENT BEGINS. THIS VERIFIES THAT ULTRAFILTRATION RATE IS AS EXPECTED. FACILITY REPORTS THAT "OBLIGATORY TESTS WERE PERFORMED" PRIOR TO OPERATING MACHINE. THIS IS HIGHLY UNLIKELY, SINCE PT REPORTEDLY LOST 2 KG. OF FLUID, NOT PROGRAMMED 0.5 KG., IN A ONE HOUR TIME PERIOD. THIS REPRESENTS A SIGNIFICANT LEAK, WHICH WOULD BE DETECTED BY AUTOTEST FUNCTION. AGAIN, AS REPORTED BY FAX, FACILITY HAD NO MAINTENANCE CONTRACT FOR MACHINES WITH CO. THIS SUPPORTS ABOVE CONCLUSION THAT MACHINES HAD NOT RECIEVED PROPER PREVENTIVE MAINTENANCE SINCE INSTALLATION OF MANCINE, SINCE IT MOST LIKELY HAD ORIGINAL DIAPHRAGMS STILL IN IT AFTER TWO YEARS OF USE. SUGGESTED PREVENTIVE MAINTENANCE SCHEDULE IS 2000 HOURS OF OPERATION OR ONE YEAR. FOLLOW-UP ACTION: PART WAS NOT AVAILBLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING A DIALYSIS TREATMENT, THERE WAS EXCESS WEIGHT REMOVAL REPORTED. THE MACHINE WAS PROGRAMMED TO REMOVE 2 KG. OF FLUID IN A FOUR HOUR TIME PERIOD. THE TREATMENT WAS STOPPED WHEN THE PT EXPERIENCED UNCONSCIOUSNESS AND AN ACUTE BLOOD PRESSURE DROP AFTER THE FIRST HOUR. PT WAS STABILIZED AND IS CURRENTLY REPORTED TO BE FINE. THE PT WAS WEIGHED AND IT WAS FOUND THAT 2 KG. OF FLUID HAD BEEN REMOVED DURING THE ONE HOUR OF TREATMENT. AN MES TECH SERVICED THE MACHINE AFTER THE INCIDENT AND REPLACED THE PRESSURE REGULATOR, PRV-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT FII GAMBRO HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R