BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3900517 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20685
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT DATE OF DEATH WAS VERIFIED FOR (B)(6) 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION, OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THE DEVICE WAS DETERMINED TO MEET ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING, BUT FAILED THE RITE FUNCTIONAL TEST FOR ACCURACY ((B)(4)). A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. UPON CONCLUSION OF THE EVALUATION, THE DIRECT CAUSE OF THE REPORTED EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH OR IF THE PATIENT WAS CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377085 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death DIANEAL PD4 AMBUFLEX 2.5%.