BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3092202 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11238
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    December 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PERITONEAL DIALYSIS (PD) PATIENT WHO SUFFERED A MAJOR HEART ATTACK AND DIED. ON AN UNKNOWN DATE, THE PATIENT WAS MOVED FROM HEMODIALYSIS TO PD, FOLLOWING UNSPECIFIED "HEART SYMPTOMS". THE DAY BEFORE THE PATIENT DIED, THE PATIENT WAS HOSPITALIZED FOR SEVERE WEAKNESS IN BOTH ARMS AND PAIN IN NECK AND BACK. THE FOLLOWING DAY, THE PATIENT EXPERIENCED A MAJOR HEART ATTACK AND DIED. NO AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE PERITONEAL DIALYSIS NURSE HAS DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194961 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H DIANEAL