BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1943235 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07467
    Event Type
    Death
    Date Received
    December 31, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST AND EVALUATION) FUNCTIONAL TEST FOR HEATER BAG TEMPERATURE TEST BUT PASSED THE RITE ELECTRICAL TEST. ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTS WERE PERFORMED AND THE DEVICE PASSED. THE DEVICE WAS POWER CYCLED WITH NO ERRORS ENCOUNTERED. AN INTERNAL INSPECTION REVEALED NO PROBLEMS. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - HEATER BAG TEMPERATURE TEST WAS UNDETERMINED. THE RITE TEST FAILURE WOULD NOT HAVE CONTRIBUTED TO THE PATIENT DEATH. AN EVENT HISTORY REVIEW WAS PERFORMED. THE DEVICE LOGS REVEALED NO ANOMALIES AND NO DRAIN OR ULTRAFILTRATION (UF) VOLUMES THAT MEET THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THERE WAS NO FAILURE OR MALFUNCTION IDENTIFIED IN THE LOGS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. A SERVICE HISTORY REVIEW INDICATES: A REVIEW OF THE PREVIOUS SERVICE RECORD, (B)(6) 2010, SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE (B)(6) FACILITY. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF RITE FLUID DELIVERED OUT OF TEMPERATURE RANGE. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO RITE FLUID DELIVERED OUT OF TEMPERATURE RANGE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. UPON COMPLETION OF THE EVALUATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INITIALLY, THE HOMECHOICE (HC) DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL) WHO DETERMINED THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST AND EVALUATION) TESTING DUE TO RITEHEATER BAG TEMP FAILED PERF SPEC-FLUID DELIVERED OUT OF SPEC. INFORMATION FROM GLOBAL PHARMACOVIGILANCE (GPV) RECEIVED BY GPV (B)(6) 2010 INDICATES: ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE NURSE INDICATED SHE NO LONGER HAS ACCESS TO THE PATIENT'S CHART AND REMEMBERS VERY LITTLE RELATED TO THE EVENT. THE NURSE CONFIRMED THE PATIENT DID EXPIRE ON AN UNKNOWN DATE IN (B)(6) 2010. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS REPORTEDLY RELATED TO A CARDIAC ISSUE AND UNRELATED TO THE BAXTER SOLUTIONS OR DEVICES. THE PATIENT WAS NOT HOSPITALIZED AT THE TIME OF DEATH. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death 1.5%, 2.5% AND 4.25% PER 2.5L/3L AND 1.5%, 2.5% AN