BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3828294 · Received May 22, 2014

    Report

    Report Number
    1416980-2014-16654
    Event Type
    Death
    Date Received
    May 22, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS AND AN EVALUATION HAS BEGUN BUT IS NOT YET COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. A REVIEW OF THE EVENT HISTORY RECORD DID NOT REVEAL ANY ISSUES THAT COULD BE RELATED TO THE REPORTED EVENT. THERE WERE NO KEYSTROKES, PROGRAMMING, USE RELATED OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE REPORTED ISSUE. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THAT DURING VISUAL INSPECTION, NO ISSUES WERE FOUND. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. ONE HOUR THERAPY WAS SUCCESSFULLY PERFORMED. PER PAL EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV EVENT IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE OF PATIENT PASSING AWAY. THE CAUSE IS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT DEATH COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). IT IS UNKNOWN IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306334 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death