BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3971061 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24826
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER WAS NOT KNOWN; THEREFORE, AN EVALUATION COULD NOT BE COMPLETED. BASED ON INSUFFICIENT REPORTED INFORMATION AND LACK OF A DEVICE EVALUATION, IT IS NOT POSSIBLE TO DETERMINE DEVICE CAUSALITY FOR THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 REPORTED THE PATIENT PASSED AWAY SUDDENLY AT HER HOME. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS REPORTED THE PATIENT DID NOT HAVE PERITONITIS AT THE TIME OF DEATH. THE PATIENT WAS NOT CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. 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
    447608 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death DIANEAL PD4 LOW CALCIUM 2.5% SINGLEBAG| DIANEAL PD4 LOW CALCIUM 1.5% SINGLEBAG