BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3971793 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24915
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THAT DURING VISUAL INSPECTION, DOOR LATCH WAS FOUND DAMAGED. THE FUNCTIONAL TEST WAS SUCCESSFULLY PERFORMED. A SHORT SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. NO FURTHER ACTION IS REQUIRED AT THIS TIME THE DEVICE WAS SERVICED ACCORDING TO REQUIRED PROCEDURES AND THE DEVICE PASSED ALL TESTS AS PER BAXTER PROCEDURES. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED RELATED TO THE REPORTED PROBLEM. 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). A REVIEW OF DEVICE HISTORY RECORD INDICATES MANUFACTURE OF THE DEVICE IS NOT RELATED TO THE REPORTED ISSUE. SHOULD THE DEVICE BE RETURNED FOR EVALUATION OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING PRIOR TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF PD THERAPY WITH A HOMECHOICE (HC) DEVICE WAS BEING PERFORMED AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED AND 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
    446636 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death