BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2822614 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04288
    Event Type
    Death
    Date Received
    November 7, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 13, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO BAXTER PRODUCTION ANALYSIS LAB (PAL) FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE ISSUE WAS NOT CONFIRMED WITH REGARDS TO THE DEVICE. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A RN CALLED BAXTER'S TECHNICAL SERVICES AND ASKED THAT A HOMECHOICE (HC) BE SWAPPED AND EVALUATED. THE RN STATED A PATIENT'S HEART HAD SLOWED DOWN AND THEY STOPPED BREATHING WHILE USING THE HC. HOWEVER, THE PATIENT WAS REVIVED. PRODUCT SURVEILLANCE MADE CONTACT WITH THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2012, REGARDING THE REPORTED INCIDENT. THE NURSE REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 FOR HYPOGLYCEMIA, ACUTE RENAL FAILURE, AND VOMITING COFFEE STAINED EMESIS. THE PD NURSE REPORTED THE PATIENT'S STATE OF HEALTH WAS VERY POOR. ON (B)(6) 2012, THE PATIENT UNDERWENT AN INSERTION OF A PD CATHETER DUE TO BEING IN ACUTE RENAL FAILURE. APPROXIMATELY 4 YEARS AGO THE PATIENT BEGAN PD THERAPY. PD THERAPY WAS DISCONTINUED IN 2010 DUE TO AN IMPROVEMENT OF RENAL FUNCTION. ONCE THE PD CATHETER WAS SURGICALLY INSERTED ON (B)(6) 2012, THE PATIENT BEGAN PD THERAPY. AT APPROXIMATELY 4 AM ON (B)(6) 2012, THE PATIENT WAS CONNECTED TO THE HOMECHOICE IN THE DWELL CYCLE OF THERAPY AND UNEXPECTEDLY EXPERIENCED A SEVERE BRADYCARDIA EPISODE AND STOPPED BREATHING. THE HOSPITAL CALLED THE CODE TEAM AND RESUSCITATED THE PATIENT. PD THERAPY WAS IMMEDIATELY DISCONTINUED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2012 AT 1:11 AM, THE PATIENT WAS REMOVED OFF ALL LIFE SUPPORT AND DIED. THE PD NURSE STATED THE HOMECHOICE MACHINE HAS BEEN PICKED UP TO BE EVALUATED. THE PD NURSE STATED THE DEATH WAS NOT RELATED TO PD THERAPY, A BAXTER DEVICE, DISPOSABLES, OR SOLUTIONS. THE PD NURSE STATED THE PATIENT'S DEATH WAS DUE TO HER EXTREMELY POOR HEALTH AND CO-MORBIDITIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| R DIANEAL PD4 1.5% AMBUFLEX