BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 20903319 · Received December 11, 2024

    Report

    Report Number
    1416980-2024-07159
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 16, 2024
    Report Date
    January 7, 2025
    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

    ADDITIONAL INFORMATION: H2, H3, H4, H6 AND H11. THE DEVICE WAS RECEIVED FOR EVALUATION. THE SAMPLE ANALYSIS WAS PERFORMED, AND NO HARDWARE DEFECT, DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE MOST RECENT THERAPIES REVEALED THE PROGRAMMED MINIMAL. INITIAL DRAIN (10ML) WAS SET BELOW THE RECOMMENDED SETTINGS (USE ERROR). PER THE HOMECHOICE CLARIA CLINICIAN GUIDE, THE PROGRAMMED MINIMUM INITIAL DRAIN SHOULD BE SET TO AT LEAST 70% OF THE EXPECTED PERITONEAL VOLUME (1400ML). BASED ON THE EVALUATION RESULTS, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE THE PROGRAMMED MINIMAL INITIAL DRAIN BEING SET TOO LOW IN THE MOST RECENT THERAPIES. BASED ON THE REVIEW OF THE THERAPY LOG DATA, USE ERROR OF THE CLARIA THERAPY PROGRAM (MINIMUM INITIAL DRAIN PROGRAMMED TOO LOW) PROBABLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER POSTAL CODE: 738750. THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING BLOATED AND COULD NOT BREATH PROPERLY DURING MULTIPLE STEPS OF THERAPY. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. THE CAREGIVER REPORTED THAT THE PATIENT PERFORMED A MANUAL DRAIN AND THAT THE "PRESCRIPTION WAS CHANGED 2 WEEKS AGO". RENAL THERAPY SERVICES (RTS) ASSISTED THE CAREGIVER TO DISCONNECT THE PATIENT AND ADVISED THE CAREGIVER TO CONTACT THE PD NURSE. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570299 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412676463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other CASSETTE