BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10083620 · Received May 22, 2020

    Report

    Report Number
    1416980-2020-02892
    Event Type
    Injury
    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 EXPERIENCED UNSPECIFIED INFECTIONS. THE CAUSE OF THE INFECTIONS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. PATIENT OUTCOMES AND ACTION WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547074 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FRESENIUS| GAMBRO