BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3944505 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23262
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. UPON ARRIVAL, THE DEVICE DID NOT MEET BAXTER SPECIFICATION AND THUS REPAIR WAS REQUIRED. DURING VISUAL INSPECTION, THE DOOR COVER AND HEATER PAN WERE FOUND DAMAGED. THE POWER ON SELF-TEST AND A ONE HOUR THERAPY WAS SUCCESSFULLY PERFORMED. FOR THE DAMAGED DOOR COVER AND HEATER PAN; DOOR COVER AND HEATER PAN ASSEMBLY WERE REPLACED RESPECTIVELY. THE UNIT WAS REPAIRED ACCORDING TO REQUIRED PROCEDURES AND IT PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY DURING SERVICE. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH DID NOT REVEAL ANY ISSUES THAT WERE RELATED TO THE REPORTED EVENT. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE, PASSED AWAY DUE TO AN UNREPORTED CAUSE. IT WAS UNKNOWN WHETHER THE PT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER THE PT WAS CONNECTED TO THE HC AT THE TIME OF DEATH OR IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421527 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death