BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2851473 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06152
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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). EVALUATION SUMMARY: THE HOMECHOICE DEVICE WAS RECEIVED AND EVALUATED FOR THE REPORTED ISSUE OF A HOME PATIENT PASSING AWAY. A REVIEW OF THE DEVICE LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV (INCREASED INTRA-PERITONEAL VOLUME) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST. THE DEVICE WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. INTERNAL AND EXTERNAL VISUAL INSPECTIONS PERFORMED REVEALED NO PROBLEMS. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE PROBLEM WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE OF THE PROBLEM WAS UNDETERMINED. A REVIEW OF MANUFACTURING RECORDS REVEALED THE DEVICE HAS BEEN REFURBISHED/SERVICED SINCE ITS ORIGINAL MANUFACTURE DATE AND THE DEVICE IS NO LONGER IN ITS ORIGINAL MANUFACTURE CONDITION. THEREFORE, NO MANUFACTURING ISSUES RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. A SERVICE HISTORY REVIEW WAS PERFORMED, REVEALING THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION AND PREVIOUS SERVICING DID NOT CONTRIBUTE TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A CONSUMER (THE PATIENT'S DAUGHTER) IN (B)(6) OF PATIENT PASSED AWAY COINCIDENT WITH EXTRANEAL THERAPY. ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL THERAPY (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED, INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). INITIALLY THE PATIENT'S DAUGHTER CONTACTED BAXTER CUSTOMER CARE CENTER TO ADVISE THAT HER MOTHER HAD PASSED AWAY. ON (B)(4) 2012, BAXTER PHARMACOVIGILANCE (B)(4) (CPV) FOLLOWED UP WITH THE PATIENT'S DAUGHTER AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT (PT) EXPIRED ON (B)(6) 2012. THE DAUGHTER REPORTED THE CAUSE OF DEATH WAS UNKNOWN. THE PT'S DAUGHTER REPORTED HER MOTHER HAD BEEN USING EXTRANEAL FOR PERITONEAL DIALYSIS (PD) THERAPY (NO FURTHER DETAIL PROVIDED). THE PT'S DAUGHTER WAS NOT SURE WHAT OTHER PRODUCTS SHE WAS USING. PER THE PT'S DAUGHTER, THE PT STARTED PD THERAPY (B)(6) 2012 (EXACT DATE UNSPECIFIED). THE DAUGHTER GRANTED CPV PERMISSION TO CONTACT THE PD UNIT ((B)(6) HOSP) FOR MORE INFORMATION. CPV HAS ADVISED, NO FURTHER INFORMATION IS AVAILABLE AND NO FOLLOW-UP WILL BE PURSUED DUE TO HOSPITAL PRIVACY CONCERNS.

    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 Death EXTRANEAL