BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3812056 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15556
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 24, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE LOGS REVEALED NO SYSTEM ERRORS, ANOMALIES, HARDWARE DEVICE FAILURES OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURES OR MALFUNCTIONS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURN INSTRUMENT TEST/ EVALUATION (RITE) TESTING. THE DEVICE FAILED THE HOMECHOICE RITE FUNCTIONAL TESTING, HOWEVER, IT WAS DETERMINED THAT THE FAILURE WAS UNRELATED TO THE REPORTED EVENT. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND FOUND NO ISSUES. AN EVALUATION OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAKS AND ALL PRESSURES WERE CORRECT & STABLE. THE DEVICE ALSO PASSED SEAL, PURGE & WET DISPOSABLE INTEGRITY TESTS. A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. UPON CONCLUSION OF THE INVESTIGATION, NO ABNORMALITIES OR FAILURES WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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 THIS DEATH WAS REPORTED TO BE CARDIAC FAILURE. FOUR DAYS PRIOR TO DEATH, THE PT WAS HOSPITALIZED FOR A MYOCARDIAL INFARCTION. IT WAS UNKNOWN IF THE PT WAS ON THE HOME CHOICE DEVICE AT THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289941 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H DIANEAL PD-4 1.5% AND 2.5% AMBUFLEX