BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4202010 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37500
    Event Type
    Death
    Date Received
    October 27, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION AND THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN, THEREFORE, A DEVICE SERVICE HISTORY REVIEW AND/OR DEVICE HISTORY REVIEW WERE NOT PERFORMED. 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 PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS REPORTED THAT DIANEAL THERAPY WAS ONGOING PRIOR TO THE PATIENT PASSING AWAY. THE PATIENT WAS NOT PERFORMING THERAPY AT THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684721 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 2.5% ULTRABAG, DIANEAL 2.5% SINGLEBAG| DIANEAL 4.25% SINGLEBAG