BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 1870865 · Received October 7, 2010

    Report

    Report Number
    9616026-2010-00012
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K072093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRISMAFLEX WITH SOFTWARE VERSION 4.10 (THE DEVICE INVOLVED IN THE INCIDENT IN (B)(6)) IS NOT SOLD IN THE UNITED STATES BUT IS A SIMILAR DEVICE TO PRISMAFLEX WITH SOFTWARE VERSION 3.2 IN 510(K) K072093. NEITHER A GAMBRO SERVICE TECHNICIAN NOR THE HOSPITAL'S BIOMED TECHNICIAN INSPECTED THIS MACHINE. THE MACHINE HAS BEEN USED CLINICALLY SINCE THE EVENT, WITH NO FURTHER ISSUES. THE DOWNLOADED HISTORY DATA FOR THE TREATMENT REVEALS THAT THE PRISMAFLEX CONTROL UNIT'S ANTICOAGULANT PUMP WAS USED WITH ONLY TWO OF THE ELEVEN FILTER SETS. THE ICU NURSE STATES THAT THE PATIENT RECEIVED A SLOW AND CONTINUOUS INFUSION OF HEPARIN DURING ALL OF THE TREATMENTS. IT IS UNKNOWN IF THE PATIENT WAS RECEIVING HEPARIN VIA ANOTHER ROUTE. THE WARNING ALARM "FILTER CLOTTED" IS GENERATED WHEN THE FILTER PRESSURE DROP IS GREATER THAN OR EQUAL TO LIMIT VALUE FIXED FOR THE FILTER IN USE, OR BOTH THE "FILTER IS CLOTTING" ADVISORY AND THE "TMP EXCESSIVE" CAUTION LIMITS ARE REACHED. IN TWO OF THE TREATMENTS, THE WARNING ALARM "FILTER CLOTTED" WAS GENERATED BEFORE THE ADVISORY ALARM "FILTER IS CLOTTING". IF THE CONDITIONS FOR BOTH OF THESE ALARMS ARE TRIGGERED, THE WARNING ALARM "FILTER CLOTTED" IS DISPLAYED ON THE PRISMAFLEX CONTROL UNIT. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING CONTINUOUS VENOVENOUS HEMOFILTRATION AT A FACILITY IN (B)(6) ON A PRISMAFLEX WITH PRISMAFLEX ST150 FILTERS SETS. OVER THE COURSE OF NINE DAYS THE FILTER SET WAS CHANGED ELEVEN TIMES AFTER THE MACHINE GENERATED THE "FILTER CLOTTED" ALARM DURING PRE BLOOD PUMP OR EFFLUENT BAG CHANGE PROCEDURES. THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT FOLLOWING SIX OF THESE EVENTS. AS A RESULT, THE PATIENT SUSTAINED A BLOOD LOSS AND ON FOUR OCCASIONS WAS TRANSFUSED WITH SIX UNITS OF PACKED RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX KDI GAMBRO LUNDIA AB 113082

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention