BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3851911 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18037
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE PRODUCT ANALYSIS LABORATORY (PAL) FOR FURTHER EVALUATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. THE DEVICE FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED ABOVE THE ALLOWABLE SPECIFICATION RANGE DURING VOLUMETRIC ACCURACY TESTING. PLEASE SEE 1416980-2014-22202 FOR THE INVESTIGATION RELATED TO THE RITE FAILURE. THE FAILURE WAS DETERMINED TO BE UNRELATED TO THE REPORTED DEATH. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE PASSED TEMPERATURE VERIFICATION AND ACCURACY CONFIRMATION TESTING. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. PER PAL EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV EVENT IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 DEATH WAS REPORTED TO BE CARDIAC ARREST. ON AN UNREPORTED DATE, THE PT¿S HEALTH WAS DECLINING. THE DAY PRIOR TO THE RECEIPT OF THIS REPORT, THE PT DIED. THE PT WAS NOT HOSPITALIZED PRIOR TO DEATH. THE PT WAS PERFORMING PD THERAPY AND HOOKED UP TO THE HC 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
    328531 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death EXTRANEAL VIAFLEX| DIANEAL PD4 2.5% AND 4.25% AMBUFLEX