BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASS. -4 PRONG, EUR.

    MDR report key: 923568 · Received September 28, 2007

    Report

    Report Number
    1423500-2007-01066
    Event Type
    Injury
    Date Received
    September 28, 2007
    Date of Event
    August 31, 2007
    Report Date
    August 31, 2007
    Manufacturer
    BAXTER HEALTHCARE SA - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED AND IS UNAVAILABLE FOR ANALYSIS. NO FURTHER MEASURES WILL BE TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THE PRODUCT LINE AND TAKE CORRECTIVE / PREVENTATIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A PHYSICIAN NOTIFIED THAT A PATIENT DEVELOPED PERITONITIS AFTER USING THE HOME CHOICE MACHINE. A LEAD HAD OCCURRED WHILE USING THE HOME CHOICE CYCLER TWO DAYS PRIOR TO THE PATIENT'S DIAGNOSIS. THE PATIENT'S SPOUSE HAD CONNECTED THE PATIENT TO THE CYCLER IN THE EVENING. THE NEXT MORNING, THE HOME CHOICE MACHINE ALARMED LOW FILL VOLUME AND A LEAK WAS DISCOVERED. THERE WAS A PUDDLE ON THE FLOOR AND THE SOLUTION BAG WAS EMPTY. THE PATIENT DISCONNECTED AT THE TIME AND DISCARDED THE CASSETTE AND THE PD SOLUTION BAG. THE PATIENT WAS HOSPITALIZED FOR THE TREATMENT OF THE PERITONITIS. PER THE REPORT, FOUR DIFFERENT GERMS WERE ISOLATED IN THE PD SAMPLE CULTURE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HS PD CATHETER WAS REMOVED. PATIENT IS CURRENTLY ON HEMODIALYSIS. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASS. -4 PRONG, EUR. HOMECHOICE CASSETTE / 78FKX FKX BAXTER HEALTHCARE SA - SINGAPORE S07E04020

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization