BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 17484209 · Received August 8, 2023

    Report

    Report Number
    1416980-2023-03983
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412088433
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D4: EXPIRATION DATE: 03/02/2028 (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO H4: DEVICE MANUFACTURE DATE: 03/02/2023 (PREVIOUSLY SUBMITTED AS NI). H10: 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 DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 FILL THREE OF THREE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION OF THE HOMECHOICE CASSETTE THAT LED TO THIS ALARM. THE LEAK WAS FURTHER DESCRIBED AS "SOLUTION WAS NOTICED UNDER THE CYCLER" AND "THE CASSETTE WAS WET". RENAL THERAPY SERVICES (RTS) ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ALARM AND ADVISED THE HP TO PERFORM MANUAL THERAPY TO COMPLETE THE THERAPY SESSION. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. 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
    325355 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23C02011 00085412088433

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOMECHOICE PRO| UNSPECIFIED PD SOLUTION BAG