BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15751540 · Received November 8, 2022

    Report

    Report Number
    1416980-2022-06063
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 8, 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 PERITONITIS MANIFESTED BY VOMITING, FEVER, HEADACHE, BACK PAIN, ABDOMINAL PAIN AND CLOUDY FLUID. TWO DAYS AFTER THE EVENT ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, TWICE A WEEK, ONGOING) AND MEROPENEM INJECTION (1GM, PER DAY, ONGOING) FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THE EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529587 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| UNKNOWN BAXTER PD DISPOSABLES| UNKNOWN PD CATHETER