BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 20582792 · Received October 31, 2024

    Report

    Report Number
    1416980-2024-06221
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED; HOWEVER, THE SHARESOURCE LOG FILES ASSOCIATED WITH HOMECHOICE CLARIA WERE REVIEWED. A REVIEW OF THE LOG FILES SHOWED THERE WERE NO FINDINGS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS NOT VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT "FELT A BIT HEAVY AND HAD DIFFICULTY TO BREATHE" DURING DWELL 2 OF 6. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. TECHNICAL SERVICE (TS) ADVISED THE PATIENT TO PERFORM A MANUAL DRAIN UNTIL THEY FELT BETTER AND THEN END THERAPY. THE PATIENT STATED THEY WANTED TO DRAIN AND THEN CONTINUE WITH THERAPY. THE DRAIN VOLUME WAS 1013 ML. THE PATIENT REPORTED THEY FELT BETTER AND WOULD CONTINUE WITH THERAPY. TS ADVISED THE PATIENT TO INFORM THE NURSE AND CONFIRM THEIR PROGRAM. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065739 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other