BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1834532 · Received September 15, 2010

    Report

    Report Number
    1423500-2010-03423
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS FOR THE CASSETTE (H10F20011, H10E26028) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE ON 8/24/2010 REGARDING A HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. THE NURSE REVEALED THAT THE PATIENT WAS IN THE HOSPITAL DUE TO SEPTICEMIA AND PERITONITIS. THE NURSE STATED THAT THE SEPTICEMIA WAS CAUSED BY FOOD POISONING. ON 09/07/2010, THE NURSE REPORTED THAT ON (B)(6)2010 THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND SEPTICEMIA. AT THE TIME OF THIS EVENT, THE PATIENT WAS 55 YEARS OLD (EXACT DATE OF BIRTH WAS UNKNOWN). SYMPTOMS OF PERITONITIS AND SEPTICEMIA WERE UNKNOWN. WHILE HOSPITALIZED, IT WAS DISCOVERED THAT THE PATIENT HAD BEEN PREVIOUSLY EXPOSED TO SALMONELLA (EXACT EXPOSURE DATE WAS UNKNOWN). WHILE HOSPITALIZED, THE PATIENT'S EFFLUENT WAS ANALYZED AND THE RESULT INDICATED THAT THE PATIENT HAD BACTERIAL PERITONITIS. TYPE OF BACTERIUM WAS UNKNOWN, BUT THE NURSE INDICATED THAT BOTH THE PERITONITIS AND THE SEPTICEMIA WERE RELATED TO SALMONELLA EXPOSURE. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. TREATMENTS FOR SALMONELLA EXPOSURE, BACTERIAL PERITONITIS AND SEPTICEMIA WERE UNKNOWN. ON (B)(6)2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT CONTINUED PD THERAPY WITHOUT CHANGE IN DOSAGE. EVENT OUTCOMES FOR SALMONELLA EXPOSURE, BACTERIAL PERITONITIS AND SEPTICEMIA WERE UNKNOWN. THE PATIENT HAD A MEDICAL HISTORY OF END STAGE RENAL DISEASE (ESRD) SECONDARY TO GLOMERULAR NEPHRITIS. THE NURSE STATED THE EVENT OF SALMONELLA EXPOSURE WAS NOT RELATED TO PD THERAPY OR DIANEAL SOLUTIONS. THE NURSE STATED THE EVENTS OF BACTERIAL PERITONITIS AND SEPTICEMIA WERE RELATED TO SALMONELLA EXPOSURE AND WERE NOT RELATED TO PD THERAPY OR DIANEAL SOLUTIONS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R (B)(4) 1.5% PD2 3L/3L DNL (B)(4) 2.5% PD2 3L/3L DN