BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2223550 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11254
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED FOR RETURN TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED AND AN EVALUATION COMPLETED OR ADDITIONAL INFORMATION RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. THE DEVICE PASSED THE HOMECHOICE RITE ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS FOUND TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. A REVIEW OF THE PREVIOUS SERVICE EVENTS FOR SERIAL NUMBER (B)(4) SHOWS THAT THE DEVICE WAS NOT RETURNED FOR ANY ISSUES RELATED TO PATIENT DEATH HOWEVER, THE ACCOMP BOARD WAS REPLACED. A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE TAMPA BAY FACILITY. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF PATIENT DEATH. THE ASSIGNABLE CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT DEATH BY A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY PERITONEAL DIALYSIS NURSES (PDN). ON (B)(6) 2011 A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. PER THE INITIAL REPORT, THE CAREGIVER (CG) REPORTED THE HOME PATIENT (HP) PASSED AWAY. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S CAREGIVER ON (B)(6) 2011 BY BAXTER GLOBAL PHARMACOVIGILANCE. THE CG REPORTED THAT ON AN UNREPORTED DATE (YEARS AGO) THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) USING DIANEAL PD4 AMBUFLEX (LOT NUMBER AND DOSAGE WERE UNKNOWN), NIGHTLY INTRAPERITONEALLY (IP). ON (B)(6) 2011, THE PATIENT EXPIRED AT HOME. THE PATIENT WAS ON HOSPICE CARE AT THE TIME OF DEATH. THE PATIENT REMAINED ON PD THERAPY UP UNTIL THE TIME OF DEATH HOWEVER IT WAS NOT REPORTED WHAT DIALYSIS SOLUTION THE PATIENT CONTINUED TO USE UP UNTIL THE TIME OF DEATH. CAUSE OF DEATH WAS UNKNOWN. ON (B)(6) 2011, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE PD NURSE. SHE WAS UNABLE TO PROVIDE A CAUSALITY ASSESSMENT STATING THE PATIENT WAS UNDER HOSPICE CARE AT THE TIME OF DEATH THEREFORE SHE COULD NOT COMMENT ON THE EVENT OF DEATH. ON (B)(6) 2011, BAXTER PRODUCT SURVEILLANCE SPOKE TO A DIFFERENT PDN AND SHE ADDED THAT THE PATIENT WENT INTO HOSPICE CARE UNDER HIS OWN CHOOSING. THE HOSPICE CARE DOES NOT PROVIDE INFORMATION TO THEM ABOUT PATIENTS AND THEIR CARE. THE PDN CONFIRMED THAT INFORMATION ON THE PATIENT'S CAUSE OF DEATH AND CAUSALITY INFORMATION WAS NOT AVAILABLE.

    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 84 YR Death DIANEAL PD4 AMBUFLEX