BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11132004 · Received January 7, 2021

    Report

    Report Number
    1416980-2021-00011
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 13, 2020
    Report Date
    January 19, 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 · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, ONGOING, ROUTE, FREQUENCY NOT REPORTED) AND CEFTAZIDIME INJECTION (1GM, ONGOING, ROUTE, FREQUENCY NOT REPORTED) FOR PERITONITIS. THREE DAYS AFTER THE EVENT ONSET, THE PATIENT WAS RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32776 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DIANEAL 2.5% PD2| EXTRANEAL| DIANEAL 2.5% PD2