BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15621464 · Received October 18, 2022

    Report

    Report Number
    1416980-2022-05537
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 17, 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

    PRODUCT SURVEILLANCE HAS ASSESSED THIS RECORD FOR REPORTABILITY USING THE DEVICE VIGILANCE ASSESSMENT DOCUMENT, GQI-05-48. PER THE INITIAL ASSESSMENT, IT HAS BEEN DETERMINED TO BE REPORTABLE AT THIS TIME.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE EVENT WAS UNKNOWN. ON THE SAME DAY AS THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT INITIATED. TWO DAYS AFTER THE EVENT ONSET, THE PATIENT'S CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS TWICE A WEEK. THE PATIENT REMAINED HOSPITALIZED AND HAS RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482840 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization COVIDIEN CATHETER| DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| EXTRANEAL 7. 5% PD2| UNKNOWN BAXTER PD DISPOSABLES