BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1308547 · Received February 5, 2009

    Report

    Report Number
    1423500-2009-00079
    Event Type
    Death
    Date Received
    February 5, 2009
    Date of Event
    December 17, 2008
    Manufacturer
    BAXTER HEALTHCARE- MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE AND WILL BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN LATE 2008, A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 / 2367 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CARE GIVER (CG) CYCLE THE POWER; SYSTEM ERROR 2367 WAS RECEIVED. THE TSR EXPLAINED THE ALARM TO THE CG AND INFORMED HER THAT SHE WOULD NEED TO START OVER WITH NEW SUPPLIES AND NOTIFY THE PERITONEAL DIALYSIS NURSE. ON 01/21/2009, THE NURSE WAS CONTACTED AND STATED THAT THE PT WENT TO THE HOSPITAL NINE DAYS AFTER THE ORIGINAL DATE. THE FAMILY NOTED THAT THE PT'S DRAIN BAGS HAD "ORANGE" FLUID, THE PT WAS DEHYDRATED, WAS NOT EATING AND WAS EXPERIENCING DIARRHEA. THE FAMILY CONTACTED THE PHYSICIAN THE SAME DAY, AND THE PT WAS HOSPITALIZED THAT DAY. THE ADMITTING DIAGNOSIS WAS ACUTE BACTERIAL PERITONITIS. THE PT WAS TREATED WITH VANOCMYCIN 1G IP BEGINNING THE SAME DAY, AND CEFAZOLIN 1GRAM INTRAVENOUS (IV) THE NEXT DAY, AND 250MG TO BE ADDED TO EACH BAG OF DIALYSATE. THE PT EXPERIENCED CARDIAC ARREST ON THAT DAY, AT APPROXIMATELY 1400. CARDIOPULMONARY RESUSCITATION WAS IMPLEMENTED, HOWEVER, THE PT EXPIRED THE SAME DAY. IT WAS UNK IF AN AUTOPSY WAS PERFORMED. THE LISTED CAUSE OF DEATH WAS STATUS POST CARDIAC ARREST. THE FACILITY NURSE INDICATED THAT THE PT REPORTEDLY HAD A BOWEL INFECTION THAT LED TO THE PERITONITIS AND THAT ULTIMATELY THE PT BECAME SEPTIC. THE DEVICE WAS RETURNED TO BAXTER, HOWEVER THERE IS NO ALLEGATION THAT THE DEVICE NOR SET WERE IMPLICATED IN THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE- MOUNTAIN HOME UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death 1.5%| EXTRANEAL SOLUTION