BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3813335 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15614
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). A REVIEW OF THE SERVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS OR SIMILAR TO THE REPORTED EVENT. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. AN EXTERNAL & INTERNAL INSPECTION WAS PERFORMED WHICH REVEALED NO ANOMALIES. AN EVALUATION OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAKS AND ALL PRESSURES WERE CORRECT & STABLE. THE DEVICE PASSED SEAL, PURGE & WET DISPOSABLE INTEGRITY TESTS AND A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. A REVIEW OF THE SERVICE HISTORY WAS PERFORMED WHICH DID NOT IDENTIFY ANY PREVIOUS SERVICING EVENTS RELATED TO THE REPORTED EVENT. PER PAL EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV EVENTS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF THE SERVICE HISTORY REVIEW WERE INCIDENTALLY REPORTED TWICE IN FOLLOW UP 001. RESULTS OF THE EVENT HISTORY LOG REVIEW WERE AVAILABLE AND INADVERTENTLY LEFT OUT. THE EVENT HISTORY LOG WAS REVIEWED AND REVEALED NO PROGRAMMING, MALFUNCTION, OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC FAILURE BUT THIS WAS NOT CONFIRMED. IT WAS REPORTED THAT THE PT WAS HOSPITALIZED 4 MONTHS PRIOR TO DEATH DUE TO LUNG CANCER AND REMAINED THERE UNTIL SHE PASSED AWAY. THE PT WAS PERFORMING THERAPY WITH THE HC DEVICE AT THE TIME OF DEATH. AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289363 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death DIANEAL 1.5% AND 2.5% AMBLFLEX THERAPY