BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4243534 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39920
    Event Type
    Death
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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. THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. WHILE HOSPITALIZED, PD THERAPY WAS ONGOING USING A HOSPITAL CYCLER. THE PATIENT WAS NOT PERFORMING THERAPY WITH A HC DEVICE AT THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED AND A DEATH CERTIFICATE WAS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727682 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death DIANEAL 1.5% ULTRABAG (LOW CALCIUM)| DIANEAL 2.5% ULTRABAG (LOW CALCIUM)