BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGRATED APD SET

    MDR report key: 19463040 · Received June 4, 2024

    Report

    Report Number
    1416980-2024-02729
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 8, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FKX
    UDI-DI
    00085412090078
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME: REPLACE HOMECHOICE AUTOMATED PD SET WITH CASSETTE WITH INTERGRATED APD SET. D3: DEVICE MANUFACTURER NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC. D4: UNIQUE IDENTIFIER (UDI) #: REPLACE NI WITH (B)(4); THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. G4: COMBINATION PRODUCT: ADD NO (PREVIOUSLY BLANK). H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TESTS WERE PERFORMED WHICH INCLUDED LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTS WITH NO ISSUES. ADDITIONALLY, MACHINE TESTING WAS PERFORMED AND NO ISSUES OR ALARMS WERE NOTED. THE REPORTED ISSUE WAS NOT VERIFIED. THE DEVICE MET SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOMECHOICE CLARIA DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL THREE OF FOUR OF PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, THE HOME PATIENT (HP) REPORTED THAT THERE WAS FLUID ON THE FLOOR. RENAL THERAPY SERVICES (RTS) HAD THE CAREGIVER (CG) CLOSE ALL THE CLAMPS AND THE TRANSFER SET. RTS ASSISTED THE HP TO DISCONNECT FROM THE THERAPY. RTS ASSISTED THE HP TO CLEAR THE ALARMS AND END THE THERAPY SESSION. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. 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
    206988 INTERGRATED APD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER INTERNATIONAL INC. NA ASKU 00085412090078

    Patients

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