BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2473380 · Received February 29, 2012

    Report

    Report Number
    1423500-2012-04927
    Event Type
    Death
    Date Received
    February 29, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). THE CUSTOMER RETURNED THE CLIENT'S HOMECHOICE DEVICE TO BAXTER AND AN INTERNAL INVESTIGATION IS UNDERWAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY AND THE DEVICE NEEDED TO BE RETURNED DUE TO THE DEVICE NO LONGER BEING NEEDED. A NUMBER OF ATTEMPTS HAVE BEEN MADE TO DETERMINE THE HOME PATIENT'S CAUSE OF DEATH, HOWEVER, THE FACILITY DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. INTERNAL & EXTERNAL VISUAL INSPECTIONS PERFORMED REVEALED NO PROBLEMS. THE DEVICE PASSED BOTH THE HOMECHOICE RITE ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. REVIEW OF THE DEVICE HISTORY FOUND NO ABNORMALITIES. A TWO (2) YEARS REVIEW OF THE SERVICE HISTORY FOR SERIAL #(B)(4) SHOWS THAT THE DEVICE WAS NOT PREVIOUSLY RETURNED TO THE BAXTER FOR ANY PRIOR SERVICING. THERE WAS NO MALFUNCTION CONFIRMED AND THE CAUSE OF THE PATIENT DEATH WAS UNDETERMINED THROUGH EVALUATION OF THE DEVICE. BAXTER HAS MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT INCLUDING CAUSE OF DEATH.

    Description of Event or Problem · 1

    DURING FOLLOW UP ON (B)(4) 2012 FOR AN UNRELATED ISSUE, PRODUCT SURVEILLANCE WAS NOTIFIED BY THE CAREGIVER THAT THE PATIENT HAD PASSED AWAY. THE HOME PATIENT'S REGISTERED NURSE REPORTED TO BAXTER THAT THE CLIENT PASSED AWAY. EXACT DATE OF DEATH IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death DIANEAL LOW CA 4.25% 6L/6L| LOW CA 1.5% 2L/2L UB DIAN| LOW CA 2.5% 2L/2L UB DIAN| HOMECHOICE PRO APD SYSTEM| DIANEAL LOW CA 1.5% 6L/6L| LOW CA 4.25% 2L/2L UB DIA| DIANEAL LOW CA 2.5% 6L/6L