BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2243703 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12080
    Event Type
    Death
    Date Received
    September 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED TO THE BAXTER FOR EVALUATION. THE DEVICE FAILED THE HOMECHOICE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TEST DUE TO RECORD START TIMES FAILED (UNIT TIMED OUT). THE HOMECHOICE RITE ELECTRICAL TEST PASSED WITH NO ISSUES ENCOUNTERED. A SHORT THERAPY WAS RUN WITH THE DEVICE WHILE BEING MONITORED WITH CRT (CYCLER REMOTE TOOLBOX) TO VERIFY COMMUNICATION INTERFACE. DURING THE INITIAL DRAIN THE DEVICE ALARMS SYSTEM ERROR (SE) 1 (SOFTWARE ERROR), AND LOSES COMMUNICATION WITH CRT. INTERNAL INSPECTION WAS PERFORMED AND IT WAS FOUND THAT THE RS232 CABLE WAS NOT SEATED FULLY IN ITS SOCKET. THE CABLE WAS RESEATED AND ANOTHER THERAPY WAS ATTEMPTED AND NO FURTHER ISSUES WERE NOTED. AN EXTERNAL INSPECTION REVEALED NO ISSUES. THE ASSIGNABLE CAUSE FOR THE RITE FUNCTIONAL TEST FAILURE AND THE ADDITIONAL ISSUE OF SE1 WAS DETERMINED TO BE CAUSED BY POOR SEATING OF THE RS232 CABLE IN ITS SOCKET ON THE DATA LOGGER PRINTED CIRCUIT BOARD (PCB). THE RITE FAILURE AND THE ADDITIONAL ISSUE OF SE1 WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT EXPIRATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD AN EVALUATION BE PERFORMED OR ADDITIONAL INFORMATION RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER. GLOBAL PHARMACOVIGILANCE INDICATED A US NURSE REPORTED A DIALYSIS PATIENT EXPERIENCED FALLS, CONFUSION, SLIT PERITONEAL DIALYSIS (PD) CATHETER, FAINTING, VOMITING, POOR PERITONEAL DIALYSIS CLEARANCE, CONVULSION AND FATAL CARDIOVASCULAR DISEASE IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. IN (B)(6) 2011, THE PATIENT'S WIFE REPORTED THAT THE PATIENT EXPERIENCED FALLS UP TO 4 TIMES A WEEK AND HAD BECOME CONFUSED. THE PATIENT CONFUSION INCREASED AND THE PATIENT FAINTED AND VOMITED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PD CATHETER WAS REMOVED AND BLOOD WAS DRAWN. IT WAS REPORTED THAT THE PATIENT'S POTASSIUM AND BUN LEVELS WERE HIGH (UNKNOWN LEVELS). IN (B)(6) 2011, THE PATIENT HAD A NEW PD CATHETER PLACED AND PD THERAPIES WERE RESTARTED WITH THE SAME REGIMEN. IN (B)(6) 2011, AFTER RESTARTING PD THERAPY, THE PATIENT'S BLOOD WAS ANALYZED. THE RESULTS REVEALED THAT THE POTASSIUM AND BUN LEVELS CONTINUED TO BE HIGH (UNKNOWN LEVELS). THE NURSE REPORTED THAT ALTHOUGH DIALYSIS WAS BEING PERFORMED CORRECTLY AND FLUID WAS BEING TAKEN OFF, IT WAS NOT CLEARING THE BLOOD OF WASTE AS EVIDENCED BY POTASSIUM AND BUN LEVELS HIGH. ON (B)(6) 2011, THE PATIENT WAS CONFUSED, FELL AND SUSTAINED INJURIES TO HIS HEAD AND ELBOWS. ON (B)(6) 2011, WHILE AT HOME CONNECTED TO THE CYCLER, THE PATIENT REPORTEDLY EXPERIENCED A CONVULSION AND LOST CONSCIOUSNESS. THE PARAMEDICS WERE CALLED. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) AND EXPIRED. THE NURSE WAS TOLD THAT BLOOD TESTS WERE PERFORMED ON THE PATIENT AND THE RESULT SHOWED THE PATIENT'S POTASSIUM LEVEL WAS VERY HIGH (UNKNOWN LEVELS). THE CAUSE OF DEATH WAS FATAL ARTERIOSCLEROTIC HYPERTENSIVE CARDIOVASCULAR DISEASE. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENTS OF CUT A SLIT UP THE PD CATHETER, NOT CLEARING THE BLOOD OF WASTE AND CONVULSION. THE NURSE CONSIDERED THE EVENT OF FATAL ARTERIOSCLEROTIC HYPERTENSIVE CARDIOVASCULAR DISEASE TO BE POSSIBLY RELATED TO THE DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES, ALTHOUGH IT WAS ALSO STATED THAT OTHER HEALTH ISSUES WERE SIGNIFICANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death LO CAL 4.25% 6L/6L| LO CAL 2.5% 6L/6L| LO CAL 2.5% 2L/2L UB| DIANEAL LO CAL 2.5% 6L/6L| LO CAL 1.5% 2L/2L UB| DIANEAL LO CAL 4.25% 6L/6L| DIANEAL LO CAL 1.5% 6L/6L| LO CAL 1.5% 6L/6L| LO CAL 4.25% 2L/2L UB