BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4223020 · Received November 4, 2014

    Report

    Report Number
    1416980-2014-38655
    Event Type
    Death
    Date Received
    November 4, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS SEPSIS AND PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENTS PRIOR TO OR AT THE TIME OF DEATH. TREATMENT FOR THE SEPSIS AND PERITONITIS WAS NOT REPORTED. DIANEAL THERAPIES WERE REPORTED TO BE ONGOING PRIOR TO AND AT THE TIME OF DEATH, BUT IT WAS NOT REPORTED IF PERITONEAL DIALYSIS THERAPY WAS BEING PERFORMED WITH A BAXTER DEVICE AND/OR BAXTER SOLUTIONS PRIOR TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT PRIOR TO PASSING AWAY. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708041 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 1.5% AND 2.5% LOAMBUFLEX| TRANSFER SET, TITANIUM ADAPTER