BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11421324 · Received March 5, 2021

    Report

    Report Number
    1416980-2021-01054
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 4, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    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 PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DATE AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THIS EVENT AND WAS DISCHARGED AFTER NINE DAYS. THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM ONCE IN 3 DAYS, ROUTE NOT REPORTED, DISCONTINUED AT THIS TIME ) AND FORTUM INJECTION (1GM, EVERY DAY, ROUTE NOT REPORTED, DISCONTINUED AT THIS TIME). AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THIS EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321728 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R DIANEAL 1.5% PD2| DIANEAL 2.5% PD2