BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10570112 · Received September 22, 2020

    Report

    Report Number
    1416980-2020-05908
    Event Type
    Injury
    Date Received
    September 22, 2020
    Report Date
    September 22, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: QUAN, L., XU, Y., LUO, S., WANG, L., LEBLANC, D. AND WANG, T. "NEGOTIATED CARE IMPROVES FLUID STATUS IN DIABETIC PERITONEAL DIALYSIS PATIENTS". PERITONEAL DIALYSIS INTERNATIONAL, (2006) VOL. 26, NO. 1, PP. 95¿100, 0896-8608/06, WWW.PDICONNECT.COM. 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 THREE PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED RECURRENT PERITONITIS. THE CAUSE OF THE PERITONITIS EVENTS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE PERITONITIS EVENTS WAS NOT REPORTED. PATIENT OUTCOMES WERE NOT REPORTED. ON AN UNREPORTED DATE, PD THERAPY WAS DISCONTINUED, AND THE PATIENTS WERE TRANSFERRED TO HEMODIALYSIS (DUE TO RECURRENT PERITONITIS). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031721 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention