BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2254028 · Received September 19, 2011

    Report

    Report Number
    1423500-2011-12382
    Event Type
    Death
    Date Received
    September 19, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB. UPON COMPLETION OF AN EVALUATED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY THE BAXTER PRODUCT ANALYSIS LAB (PAL) OPERATIONAL AND IN GOOD CONDITION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST AND EVALUATION) FUNCTIONAL TEST FOR TIMING OUT DURING DRAIN 1 BUT PASSED THE RITE ELECTRICAL TEST. A REVIEW OF THE DEVICE LOGS REVEALED NO ANOMALIES, HOWEVER A DRAIN VOLUME WAS IDENTIFIED THAT MEETS THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA AND IS ADDRESSED UNDER MANUFACTURER REPORT NUMBER: 1423500-2011-10176. THE PRODUCT ANALYSIS LAB PERFORMED AN EVALUATION. THE CRT (CYCLER REMOTE TOOLBOX) SOFTWARE WAS USED TO DIAGNOSE THE DEVICE'S PNEUMATIC SYSTEM. NO LEAKS WERE DETECTED; ALL PRESSURES WERE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTS WERE PERFORMED AND COMPLETED SUCCESSFULLY. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. THE DEVICE FUNCTIONED PROPERLY DURING THE EVALUATION. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - TIMEOUT DURING DRAIN 1 WAS UNDETERMINED. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 1

    INITIALLY, THE CUSTOMER RETURNED THE HOMECHOICE DEVICE TO THE BAXTER FOR AN UNRELATED ISSUE. ON (B)(6) 2011, GLOBAL PHARMACOVIGILANCE INDICATED A USA NURSE REPORTED A MYOCARDIAL INFARCTION IN A MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). TREATMENT WAS NOT REPORTED FOR THE MYOCARDIAL INFARCTION. ON (B)(6) 201 THE PATIENT DIED OF A MYOCARDIAL INFARCTION. DIANEAL THERAPY WAS ONGOING AT THE TIME OF DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE LISTED CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. ON (B)(6) 2011, THE NURSE CONFIRMED THE MYOCARDIAL INFARCTION WAS ASSOCIATED WITH UNDERLYING CARDIAC DISEASE AND UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O 1.5% LO/CAL UB 2L/2L DIANEAL| 2.5% LO/CAL 6L DIANEAL| 4.25% LO/CAL UB 2L/2L DIANEAL| 1.5% LO/CAL 6L DIANEAL| 2.5% LO/CAL UB 2L/2L DIANEAL| 4,25% LO/CAL 6L DIANEAL