BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8921620 · Received August 22, 2019

    Report

    Report Number
    1416980-2019-04583
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH FORTUM (1 GRAM, ROUTE, FREQUENCY AND DURATION WERE NOT REPORTED), AMIKACIN (125 MG, ROUTE, FREQUENCY AND DURATION WERE NOT REPORTED) AND VANCOMYCIN (1 GRAM, EVERY 5TH DAY, ROUTE AND DURATION WAS NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. ACTION WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713970 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| EXTRANEAL 7.5% PD2