BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6157892 · Received December 9, 2016

    Report

    Report Number
    1416980-2016-18197
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 9, 2016
    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 THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH VANCOMYCIN, 2 GRAMS PER 5 DAYS AND GENTAMICIN, 20 MILLIGRAMS PER DAY (THE ROUTES OF ADMINISTRATION WERE NOT REPORTED). THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814770 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention