BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 19183019 · Received April 25, 2024

    Report

    Report Number
    1416980-2024-01898
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412676463
    PMA / PMN Number
    K201867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HOMECHOICE CLARIA WERE REVIEWED. A REVIEW OF THE MOST RECENT THERAPY SHOWED THAT THE PATIENT¿S AVERAGE UF FOR THE SEVEN MOST RECENTLY COMPLETED THERAPIES WAS APPROXIMATELY 650 ML AND THAT THE PATIENT'S PROGRAMMED TOTAL UF (250 ML) WAS SET TOO LOW FOR THE MOST RECENT THERAPIES. THERE WAS NO DEVICE MALFUNCTION IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE DEVICE LOG ANALYSIS, THE MOST PROBABLE CAUSE WAS DETERMINED TO BE THE PROGRAMMED TOTAL UF BEING SET TOO LOW. PER THE CLARIA CLINICIAN GUIDE, THE PRODUCT LABELLING WARNS USERS AND CLINICIANS THAT THIS MAY LEAD TO ACCUMULATION OF PERITONEAL FLUID DURING THE COURSE OF THERAPY, BECAUSE OF THE UNDRAINED UF, WHICH MAY CAUSE SYMPTOMS IN SOME PATIENTS. 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 AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED SHORTNESS OF BREATH DURING A FILL. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. THE PATIENT REQUESTED TO END THERAPY AND WANTED TO DRAIN. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH ENDING THERAPY AND A MANUAL DRAIN. THE FILL VOLUME WAS 1970 ML. RTS INITIATED A SWAP OF THE DEVICE AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. 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
    1606146 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412676463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other