BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2990033 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05271
    Event Type
    Death
    Date Received
    March 5, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW AND A SERVICE HISTORY RECORD REVIEW WERE PERFORMED AND REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE PATIENT PASSED AWAY. ACCORDING TO THE REPORT, THE PATIENT HAD MULTIPLE UNKNOWN ALARMS ON THEIR HOMECHOICE OVER THE TWO DAYS PRIOR TO DEATH. IT IS UNKNOWN IF THE PATIENT RECEIVED THEIR PD TREATMENTS DURING THOSE TWO DAYS. THE DAY AFTER THE ALARMS OCCURRED, THE PATIENT'S WIFE CALLED THE PARAMEDICS DUE TO THE PATIENT'S COMPLAINTS OF SHORTNESS OF BREATH. THE PATIENT CODED WHEN HE ARRIVED AT THE HOSPITAL AND PASSED AWAY. IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE OR RECEIVED PD TREATMENT ON THAT DAY. THE CONSUMER STATED THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE; HOWEVER, AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94313 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death DIANEAL 2.5%