BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICEPRO AUTOMATED PD SYSTEM

    MDR report key: 7292483 · Received February 22, 2018

    Report

    Report Number
    MW5075451
    Event Type
    Death
    Date Received
    February 22, 2018
    Date of Event
    October 23, 2017
    Report Date
    February 20, 2018
    Manufacturer
    BAXTER
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY MOTHER STARTED HOME DIALYSIS IN (B)(6) 2017. ON MONDAY ((B)(6) 2017) MORNING WHEN SHE WOKE UP AND WENT TO THE BATHROOM SHE SAID SHE FELT SHORT OF BREATH. SHE SAID SHE FELT LIKE SHE WAS PREGNANT AND IT FELT LIKE A BALLOON WAS DEFLATING IN HER BELLY DURING HER LAST DRAIN CYCLE. IT WAS THE FIRST TIME SHE FINISHED DIALYSIS WITH A NEGATIVE READING. SHE DETACHED HERSELF, WEIGHED HERSELF, AND WAS ABOUT TO CALL DAVITA HERE IN (B)(6) TO TALK TO THEM ABOUT IT WHEN SHE WENT INTO SUDDEN CARDIAC ARREST. I CALLED 911, EMS CAME AND WORKED ON HER AND BROUGHT HER TO THE ER AT (B)(6) MEDICAL CENTER IN (B)(6) WHERE THEY WORKED ON HER AND ULTIMATELY ADMITTED HER TO THE ICU. SHE HAD MINIMAL BRAIN ACTIVITY AND WAS PLACED IN A MEDICALLY INDUCED COMA. WHEN THEY BROUGHT HER OUT OF THE COMA THERE WAS NO CHANGE. SHE WAS DECLARED BRAIN DEAD ON THURSDAY ((B)(6) 2017). I STILL HAVE THE BAXTER HOMECHOICEPRO MACHINE AND THE PRO CARD THAT GOES WITH IT. I BELIEVE SHE WAS EXPERIENCING OVERFILL/IIPV (INCREASED INTRAPERITONEAL VOLUME) WHICH CAUSED THE SUDDEN CARDIAC ARREST WHICH ULTIMATELY LED TO HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131641 HOMECHOICEPRO AUTOMATED PD SYSTEM HOMECHOICEPRO AUTOMATED PD SYSTEM FKX BAXTER 53 8310 R

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R| S