BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGRATED APD SET

    MDR report key: 20965361 · Received December 18, 2024

    Report

    Report Number
    1416980-2024-07368
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 23, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. G1 MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - MOUNTAIN HOME 1900 N HIGHWAY 201 MOUNTAIN HOME, AR 72653 UNITED STATES. BAXTER HEALTHCARE - DOMINICAN REPUBLIC CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000 DOMINICAN REPUBLIC. 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 THAT THE SUPPLY LINE OF THE HOMECHOICE CASSETTE WAS DAMAGED; FURTHER DESCRIBED AS ¿COLLAPSED SUPPLY LINE¿. THIS OCCURRED DURING SET UP OF 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
    2083431 INTERGRATED APD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER INTERNATIONAL INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA.| UNSPECIFIED PD SOLUTION.