BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 515873 · Received March 11, 2004

    Report

    Report Number
    1423500-2004-00144
    Event Type
    Death
    Date Received
    March 11, 2004
    Date of Event
    November 25, 2003
    Report Date
    February 12, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CONVERSATION FOR AN UNRELATED REASON, THE HOME PT'S NURSE REPORTED THAT THE HOME PT HAD EXPIRED IN 2003 WITH THE CAUSE OF DEATH LISTED ON THE ESRD DEATH NOTIFICATION AS SEPTICEMIA (DUE TO PERIPHERAL VASCULAR DISEASE, GANGRENE) WITH SECONDARY CAUSES AS FUNGAL PERITONITIS AND PULMONARY INFECTION. THE HOME PT PRESENTED TO THE CLINIC IN 2003 WITH ABDOMINAL PAIN, CLOUDY EFFLUENT, VOMITING AND NAUSEA. EFFLUENT CULTURES WERE TAKEN AT THAT TIME AND THE PT WAS DIAGNOSED WITH PERITONITIS. THE NEXT DAY THE PT WAS PRESCRIBED FORTAZ 1G, INTRAPERITONEAL, ONCE DAILY FOR 3 DAYS. EFFLUENT CULTURES SHOWED CANDIDA ALBICANS GROWTH IN 2003; THE PT WAS ADVISED TO GO TO THE HOSP. PT WAS ADMITTED THE SAME DAY WITH A DIAGNOSIS OF CANDIDA PERITONITIS AND GANGRENE OF SEVERAL TOES ON THEIR RIGHT FOOT. THE HOSP STATED THAT DESPITE THE REMOVAL OF THEIR PD CATHETER, ANTIFUNGAL ANTIBIOTICS, REMOVAL OF THE GANGRENOUS TOES AND APPROPRIATE ANTIMICROBIAL ANTIBIOTICS THE PT DETERIORATED, DEVELOPED RESPIRATORY FAILURE ARDS, MULTIORGAN FAILURE SYNDROME AND EXPIRED TEN DAYS LATER. THE HOME PT'S NURSE REPORTED NO KNOWN ORIGIN FOR THE DIAGNOSED PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death HOMECHOISE AUTOMATED PD SYSTEM 115 VOLT, 2003,| DIANEAL SOLUTION (STRENGTH UNK), 2003.| CAPD TRANSFER SET, 2003,