BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3910224 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21264
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DURING EVALUATION, THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTING AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. NO FAILURE OR MALFUNCTION OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED BY THE CARE GIVER TO BE A MYOCARDIAL INFARCTION. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) WAS UNABLE TO CONFIRM THE CAUSE OF DEATH AND REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT HAD BEEN FOUND UNRESPONSIVE AT THEIR NURSING HOME AND WAS BROUGHT TO THE HOSPITAL. THE PATIENT LATER PASSED AWAY IN THE EMERGENCY ROOM THE SAME DAY. PERITONEAL DIALYSIS THERAPY WAS ONGOING UNTIL THE TIME OF DEATH HOWEVER, THE PATIENT WAS NOT PERFORMING THERAPY WITH THE HOMECHOICE DEVICE WHEN THEY WERE FOUND UNRESPONSIVE. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386529 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death DIANEAL PD4 AMBUFLEX AND EXTRANEAL