BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 17497595 · Received August 10, 2023

    Report

    Report Number
    1416980-2023-04007
    Event Type
    Injury
    Date Received
    August 10, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). STUDY ARTICLE: EL SHAMY, O., ATTALAH, S., SHARMA, S., AND URIBARRI, J. "COMPARING THE EFFECT OF PERITONEAL DIALYSIS CYCLER TYPE ON PATIENT-REPORTED SATISFACTION, SUPPORT NEEDS AND TREATMENTS". BMC NEPHROLOGY, (2002) 23:217 1 ¿ 5. HTTPS://DOI.ORG/10.1186/S12882-022-02854-Z. 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 STUDY WAS PERFORMED IN WHICH 12 AUTOMATED PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED PERITONITIS. TWO OF THE PATIENTS PRESENTED TO THE EMERGENCY ROOM AND WERE HOSPITALIZED FOR THE EVENTS. THE CAUSE, 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
    851922 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization AMIA CYCLER