BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGRATED APD SET

    MDR report key: 20635933 · Received November 7, 2024

    Report

    Report Number
    1416980-2024-06372
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 12, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FKX
    UDI-DI
    00085412090078
    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 G1: DEVICE MANUFACTURER ADDRESS 1: CARRETERA SANCHEZ KM 18.5 (PREVIOUSLY SUBMITTED AS PIISA INDUSTRIAL PARK ANTIGUA). CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 2: PARQUE INDUSTRIAL ITABO, PIISA (PREVIOUSLY SUBMITTED AS CARRETERA SANCHEZ KM 18 1/2). ADDITIONAL INFORMATION WAS ADDED TO H6 AND H11. H11: 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 NOT RECEIVED FOR EVALUATION; 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 DWELL THREE OF THREE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ASSISTED THE HOME PATIENT (HP) TO REMOVE THE SUPPLIES AND ADVISED THEM TO CONTACT THEIR NURSE REGARDING THE ISSUE. 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
    1815864 INTERGRATED APD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER INTERNATIONAL INC. NA H24F28059 00085412090078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HOMECHOICE.| UNSPECIFIED PD SOLUTION BAG.