BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET

    MDR report key: 19594943 · Received June 24, 2024

    Report

    Report Number
    1416980-2024-03135
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 26, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FKX
    UDI-DI
    00085412088433
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1: THE DEVICE WAS MANUFACTURED AT ONE OF THE FOLLOWING FACILITIES: 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.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D3: DEVICE MANUFACTURER NAME: BAXTER INTERNATIONAL INC. (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION) ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6 AND H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. 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 FROM AN UNSPECIFIED LOCATION. LIQUID WAS FOUND ON THE FLOOR ORIGINATING FROM CYCLER AND OUT ABOUT THREE FEET. THE BAGS ON THE TOPMOST SHELF WERE SATURATED IN FLUID AND ALL THE LINES COMING OUT FROM THE BAGS WERE ALSO WET. THIS WAS OBSERVED DURING USE 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
    2157087 AUTOMATED PD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER INTERNATIONAL INC. NA ASKU 00085412088433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE.| PHYSIONEAL 40 2.5%.