BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4251025 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40574
    Event Type
    Death
    Date Received
    November 14, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS, EVENT HISTORY LOG REVIEW, SERVICE HISTORY REVIEW, AND DEVICE HISTORY REVIEW COULD NOT BE COMPLETED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 UNKNOWN IF PD THERAPY WAS ONGOING OR IF THE PATIENT WAS ON THE HC DEVICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737187 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 2.5% SINGLEBAG.