BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3920104 · Received July 8, 2014

    Report

    Report Number
    1416980-2014-21848
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 13, 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

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT PASSED AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP, IT WAS REPORTED THAT PRIOR TO PASSING AWAY, THE PATIENT WAS IN THE HOSPITAL WITH PERITONITIS. THE PATIENT HAD BEEN PLACED ON HOSPICE 48 HOURS PRIOR TO PASSING AWAY. THE CAUSE OF DEATH WAS UNKNOWN. 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. PRIOR TO DEATH, THE PATIENT WAS HOSPITALIZED FOR ANOTHER INDICATION. PD THERAPY WAS ONGOING WHILE THE PATIENT WAS HOSPITALIZED HOWEVER IT WAS UNKNOWN IF THE PATIENT WAS ON THE HC DEVICE 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
    396831 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death DIANEAL 1.5% AMBUFLEX AND DIANEAL 2.5% AMBUFLEX| DIANEAL 1.5% AND 4.25% ULTRABAG