BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15666208 · Received October 25, 2022

    Report

    Report Number
    1416980-2022-05676
    Event Type
    Injury
    Date Received
    October 25, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EVENT OCCURRED ON AN UNREPORTED DATE IN (B)(6) 2022. 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 · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED AND TREATED WITH VANCOMYCIN INJECTION (1GM EVERY 5THDAY, DISCONTINUED) AND FORTUM INJECTION (1GM DAILY, DISCONTINUED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERED FROM THE EVENT. PD THERAPY WAS DISCONTINUED, THE PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744348 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Hospitalization| R UNKNOWN BAXTER PD DISPOSABLES| UNKNOWN MITRA SOLUTIONS