BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 12729699 · Received November 1, 2021

    Report

    Report Number
    1416980-2021-06528
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 1, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K201867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 EVENT LOG NOTED THAT THE INITIAL DRAIN ALARM (IDA) SETTING WAS PROGRAMMED TOO LOW AT 0 ML. PER THE HOMECHOICE CLARIA APD SYSTEM PATIENT AT-HOME GUIDE IF THE PREVIOUS THERAPY ENDED EARLY FOR ANY REASON OR AN OFF-CYCLER EXCHANGE WAS PERFORMED, THERE MAY BE MORE FLUID IN YOUR PERITONEAL CAVITY THAN NORMAL. IF THIS OCCURS, THE IDA ALARM SETTING MAY BE TOO LOW. THE PROGRAMMED I-DRAIN ALARM SHOULD BE SET TO AT LEAST 70% OF THE PROGRAMMED LAST FILL VOLUME. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE PROBABLE CAUSE OF THE EVENT WAS DETERMINED TO BE THE PROGRAMMED I-DRAIN ALARM BEING SET TOO LOW. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED A HARD TIME TO BREATH DURING FILL 1 OF 5. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. THE CAREGIVER REPORTED THAT DURING PATIENT HOSPITALIZATION THE NURSE PERFORMED A MANUAL DRAIN OF 586ML, THEN A MANUAL FILL WAS PERFORMED WITH AN INITIAL DRAIN AMOUNT OF 0ML, INITIAL DRAIN VOLUME OF 186ML. THERAPY SERVICES (TS) ASSISTED THE CAREGIVER WITH STOPPING THE FILL WITH FILL VOLUME OF 1686ML. TS ASSISTED TO PERFORM A MANUAL DRAIN. THE LAST FILL VOLUME WAS 2732ML, AND THE CAREGIVER REPORTED IT WAS A LITTLE OVER 3800ML. TS ASSISTED TO END THERAPY AND THE PATIENT REPORTED THEY FELT BETTER. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. THERE WAS NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630192 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other