BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3771916 · Received April 25, 2014

    Report

    Report Number
    1416980-2014-13288
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    February 22, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)94). THE SERIAL NUMBER OF THE DEVICE WAS ACTUALLY (B)(4), AND NOT THE PREVIOUSLY REPORTED (B)(4). THE EXPIRATION DATE OF THE DEVICE IS "NOT APPLICABLE" AND THE MANUFACTURING DATE WAS UPDATED BECAUSE IT WAS UNKNOWN.

    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 COMPLETED TO INVESTIGATE THE REPORTED DEATH. HOWEVER, THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT¿S HEIGHT IS 172.5 CM. THE PATIENT WEIGHT IS (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) PASSED AWAY DUE TO AN UNKNOWN CAUSE. EIGHT DAYS PRIOR TO DEATH, THE PT WAS ADMITTED TO THE HOSPITAL FOR ANOTHER INDICATION. SUBSEQUENTLY, THE PT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. DURING HOSPITALIZATION, PD THERAPY WAS ONGOING, HOWEVER, IT WAS UNKNOWN IF THE PT WAS UNDERGOING PD THERAPY AT THE TIME OF DEATH. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251565 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death DIANEAL PD4, 2.5% AMBUFLEX