BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGRATED APD SET

    MDR report key: 19742962 · Received July 15, 2024

    Report

    Report Number
    1416980-2024-03618
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 23, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FKX
    UDI-DI
    00085412090078
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D3: DEVICE MANUFACTURER NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC. G4: COMBINATION PRODUCT: ADD NO (PREVIOUSLY BLANK). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 THAT A HOMECHOICE CASSETTE LEAKED. THIS OCCURRED DURING SET UP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257827 INTERGRATED APD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER INTERNATIONAL INC. NA H24E03021 00085412090078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HOMECHOICE CLARIA