BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3874688 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19135
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE INITIAL REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURES, MALFUNCTIONS OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORKS OR DEVIATIONS RELATED TO THE PATIENT PASSING AWAY. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. ANALYSIS OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAKS AND ALL PRESSURES WERE FOUND TO BE CORRECT AND STABLE. THE DEVICE PASSED SEAL, PURGE AND WET DISPOSABLE INTEGRITY TESTS AND A SIMULATED THERAPY WAS SUCCESSFULLY COMPLETED. UPON CONCLUSION OF THE INVESTIGATION, NO FAILURES, MALFUNCTIONS, OR ABNORMALITIES WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352564 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death DIANEAL 1.5% PD4 AMBUFLEX