BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 16365419 · Received February 13, 2023

    Report

    Report Number
    1416980-2023-00455
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 18, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO B5, D1, D4 (CATALOGUE #), G1, (MANUFACTURER LOCATION), G4, H3, H6 AND H10. B5: THE DESCRIPTION OF THE DEVICE IS AN INTEGRATED APD SET W/CASSETTE-3 PRONG (DESCRIBED AS SUPPLY LINE ON INITIAL). G1: THE DEVICE WAS MANUFACTURED AT EITHER: BAXTER HEALTHCARE ¿ MOUNTAIN HOME, 1900 N HIGHWAY 201, MOUNTAIN HOME, AR 72653, UNITED STATES OR BAXTER HEALTHCARE ¿ DOMINICAN REPUBLIC, (B)(6) KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA, HAINA, SAN CRISTOBAL, 91000, DOMINICAN REPUBLIC (UNKNOWN ON INITIAL). H10: 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. ADDITIONALLY, THE DEVICE WAS TESTED ON A HOMECHOICE DEVICE 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 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, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE SUPPLY LINE. THE LEAK WAS FURTHER DESCRIBED AS, ¿LEAK FROM THE SUPPLY LINE COMING OUT FROM THE DEVICE¿. RENAL THERAPY SERVICES (RTS) ASSISTED THE CARE GIVER WITH CLEARING THE ALARM, ENDING THE THERAPY SESSION, AND DISCONNECTING THE PATIENT FROM THE DEVICE. THERE WAS NO 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
    721252 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOMECHOICE DEVICE