BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4130879 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33957
    Event Type
    Death
    Date Received
    September 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN. THE SERVICE HISTORY REVIEW AND/OR DEVICE HISTORY REVIEW WERE NOT PERFORMED AS PART OF THE INVESTIGATION. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT DEATH COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608216 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 2.5% SOLUTION