BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2183414 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09952
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION -LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE BAXTER INITIAL AWARE AND ALERT DATE SHOULD HAVE BEEN REPORTED AS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AT THE TAMPA BAY FACILITY OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THE DEVICE WAS EVALUATED. NO LEAKS WERE DETECTED; ALL PRESSURES WERE CORRECT AND STABLE. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. A REVIEW OF THE DEVICE LOGS REVEALED NO ANOMALIES AND NO DRAIN OR ULTRA-FILTRATION (UF) VOLUMES THAT MEET THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THE PAL DID NOT CONFIRM ANY DEVICE FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE ROOT CAUSE IS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INITIALLY, THE FACILITY NURSE CALLED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE FOR ASSISTANCE WITH THE CASSETTE. DURING A FOLLOW UP CALL THE NURSE INDICATED THAT THE PATIENT HAD EXPIRED. ADDITIONAL INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) ON (B)(6) 2011 WHICH INDICATES: THE FACILITY NURSE INDICATED THE PATIENT STARTED PERITONEAL DIALYSIS (B)(6) 2011 WITH DIANEAL AMBUFLEX SOLUTION INTRAPERITONEAL FOR END STAGE RENAL DISEASE (ESRD). IN (B)(6) 2011 THE PATIENT WAS HOSPITALIZED FOR A LEFT TOE AMPUTATION. WHILE HOSPITALIZED, THE PATIENT FELL AND BROKE HIS RIGHT HIP. RIGHT HIP REPLACEMENT SURGERY WAS PERFORMED. ON (B)(6) 2011, THE PATIENT LEFT THE HOSPITAL AGAINST MEDICAL ADVICE. ON (B)(6) 2011, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CARDIAC ARREST. A SECOND FOLLOW UP CALL WAS MADE TO THE FACILITY NURSE ON (B)(6) 2011 FOR ADDITIONAL INFORMATION RELATED TO THE PATIENT DEATH. THE NURSE INDICATED THE PATIENT HAD EXPIRED AT HOME ON AN UNKNOWN DATE DUE TO AN UNKNOWN CAUSE. THE NURSE INDICATED SHE HAS NO FURTHER INFORMATION RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O DIANEAL PD2 AMBUFLUEX