BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15952596 · Received December 9, 2022

    Report

    Report Number
    1416980-2022-06776
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    November 8, 2022
    Report Date
    December 9, 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

    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 FUNGAL PERITONITIS. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AS EVENT ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, DISCONTINUED AFTER 8 DAYS) AND MEGNOVA INJECTION (1GM, DISCONTINUED AFTER 8 DAYS) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THE EVENT. PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS (THRICE A WEEK). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2916740 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| EXTRANEAL 7.5% PD2| UNKNOWN BAXTER PD DISPOSABLE| UNKNOWN PD CATHETER