BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 10083759 · Received May 22, 2020

    Report

    Report Number
    1416980-2020-02893
    Event Type
    Death
    Date Received
    May 22, 2020
    Report Date
    May 22, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LITERATURE ARTICLE: BOUDVILLE, N., ULLAH, S., CLAYTON, P., SUD, K., BORLACE, M., BADVE, S., CHAKERA, A., AND JOHNSON, D.W. "DIFFERENCES IN PERITONEAL DIALYSIS TECHNIQUE SURVIVAL BETWEEN PATIENTS TREATED WITH PERITONEAL DIALYSIS SYSTEMS FROM DIFFERENT COMPANIES". NEPHROLOGY DIALYSIS TRANSPLANT (2019) 34: 1035¿1044. DOI: 10.1093/NDT/GFY340. THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A STUDY WAS PERFORMED IN WHICH AN UNKNOWN NUMBER OF PERITONEAL DIALYSIS (PD) PATIENTS PASSED AWAY. THE CAUSE OF THE DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AUTOPSIES WERE PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546610 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FRESENIUS| GAMBRO