BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3854345 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18242
    Event Type
    Death
    Date Received
    June 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE PATIENT PASSED AWAY. THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THE DEVICE WAS TESTED AND PASSED BOTH THE FUNCTIONAL AND ELECTRICAL TEST. THE DEVICE WAS DETERMINED TO MEET SPECIFICATION REQUIREMENTS PER RITE TESTING. EXTERNAL & INTERNAL INSPECTION WAS PERFORMED AND REVEALED NO PROBLEMS. THERE WAS NO EVIDENCE OF FLUID OR MOISTURE FOUND WITHIN THE DEVICE. ANALYSIS OF THE DEVICE PNEUMATIC SYSTEM WAS PERFORMED AND REVEALED NO LEAK AND ALL PRESSURES WERE CORRECT & STABLE. DEVICE PASSED SEAL, PURGE & WET DISPOSABLE INTEGRITY TEST AND SUCCESSFULLY COMPLETED A SHORT SIMULATED THERAPY. THE PAL ANALYZED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PATIENT¿S DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332891 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death