BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 16950020 · Received May 17, 2023

    Report

    Report Number
    1416980-2023-02415
    Event Type
    Injury
    Date Received
    May 17, 2023
    Report Date
    May 17, 2023
    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

    A2: AGE AT TIME OF EVENT: 25 YEARS TO 82 YEARS OLD. B3: EVENT DATE: (B)(6) 1994, UNTIL (B)(6) 2008. LITERATURE ARTICLE: "LOW IMMUNOGLOBULIN G CONCENTRATIONS ARE NOT ASSOCIATED WITH AN INCREASED RISK OF PERITONEAL DIALYSIS-RELATED PERITONITIS." BIEBUYCK GKM, JAKULJ L, NERADOVA A AND KREDIET RT. CLIN NEPHROL. 2023 APR;99(4):180-186. DOI: 10.5414/CN110966. 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

    IT WAS REPORTED 120 PATIENTS UNDERWENT A STUDY IN WHICH 120 PERITONEAL DIALYSIS (PD) PATIENTS USED UNKNOWN PD BAXTER DISPOSABLES. THE MEDIAN NUMBER OF PERITONITIS EPISODES PER 12 PATIENT MONTHS WAS 0.61 (0 ¿ 3.35) AND THE MEAN NUMBER OF RECURRENT PERITONITIS EPISODES WAS 0.085 ± 0.22 EPISODES PER 12 PATIENT MONTHS. THE CAUSE OF THE PERITONITIS EVENTS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED. TREATMENT FOR THE EVENTS WAS NOT REPORTED. PATIENT OUTCOMES WERE NOT REPORTED. IT WAS REPORTED 27.5% OF PATIENTS TRANSFERRED TO HEMODIALYSIS, AND FIVE TO CONSERVATIVE CARE, 34 PATIENTS RECEIVED A KIDNEY TRANSPLANT AND 12 PATIENTS CONTINUED PD TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706273 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other DIANEAL| PHYSIONEAL| SERUM IGG