BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 17298672 · Received July 11, 2023

    Report

    Report Number
    1416980-2023-03473
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 10, 2023
    Report Date
    October 2, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY FEVER, ABDOMINAL PAIN, AND CLOUDY PERITONEAL FLUID. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE SAME DAY AS THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH "G3G" (5MG/KG/J, INTRAVENOUS, DISCONTINUED AFTER 10 DAYS) FOLLOWED BY (1G/J, INTRAPERITONEAL, DISCONTINUED AFTER 10 DAYS), GENTAMYCINE (3MG/KG/J, INTRAVENOUS, DISCONTINUED AFTER 2 DAYS) FOLLOWED BY GENTAMYCINE (4MG/J, INTRAPERITONEAL, DISCONTINUED AFTER 10 DAYS) FOR PERITONITIS. TEN DAYS AFTER THE EVENT ONSET, THE PATIENT WAS TREATED WITH AMIKACINE (INTRAPERITONEAL, DISCONTINUED AFTER 10 DAYS) FOR PERITONITIS. TWENTY DAYS AFTER THE EVENT ONSET, THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (INTRAPERITONEAL) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERED FROM PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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

    THREE PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED PERITONITIS. THE CAUSE, HOSPITALIZATION, TREATMENT, PATIENT OUTCOMES AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147610 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Other| R| H HOMECHOICE DISPOSABLE SETS WITH CASSETTE| MINICAP