BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 20734368 · Received November 20, 2024

    Report

    Report Number
    1416980-2024-06655
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 26, 2024
    Report Date
    December 20, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412676463
    PMA / PMN Number
    K201867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 THE HOMECHOICE CLARIA WERE REVIEWED. A REVIEW OF THE MOST RECENT THERAPY INITIATED ON THE DATE OF THE REPORTED EVENT SHOWED THE DEVICE PROGRAMMING REVEALED THE PROGRAMMED TOTAL UF (400ML) WAS SET TOO LOW FOR THE MOST RECENT THERAPIES. PER THE CLARIA CLINICIAN GUIDE, THE PROGRAMMED TOTAL UF SHOULD BE BASED ON AN AVERAGE OF THE NIGHTLY UF FROM THE PAST SEVEN CONSECUTIVE THERAPIES FOR A SPECIFIC PROGRAM. THE LOG DATA OF THE SHOWED THE PATIENT¿S AVERAGE UF WAS APPROXIMATELY 1900ML. BASED ON THE DEVICE LOG ANALYSIS, THE DIRECT CAUSE WAS DETERMINED TO BE THE PROGRAMMED TOTAL UF BEING SET TOO LOW (USE ERROR). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER POSTAL CODE: 738750. 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 EXPERIENCED BLOATING DIFFICULTY BREATHING DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO PERFORM A MANUAL DRAIN. THE TOTAL VOLUME REPORTED WAS 12,000ML. RTS ADVISED THE PATIENT TO CONTACT THE PD NURSE TO INFORM THEM OF THEIR SYMPTOMS AND THAT THEY MISSED PD THERAPY. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481329 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412676463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other