BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 4200239 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37286
    Event Type
    Death
    Date Received
    October 24, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT LINKED TO THE REPORTED DEATH UNTIL AFTER THE DEVICE HAD BEEN SERVICED, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, 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 DEATH. A HOMECHOICE RETURN INSTRUMENT TEST /EVALUATION (RITE), THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTING AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE PATIENT PASSING AWAY. AS A RESULT, THE DIRECT CAUSE OF THE REPORTED PROBLEM WAS UNDETERMINED. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE A CARDIAC ARREST. THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH FOR AN UNRELATED ISSUE. IT WAS UNKNOWN IF THE PATIENT WAS PERFORMING THERAPY UP TO THE TIME OF DEATH. 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
    679798 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 2.5% SINGLEBAG, DIANEAL 4.25%