BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 20273112 · Received September 20, 2024

    Report

    Report Number
    1416980-2024-05167
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 31, 2024
    Report Date
    October 25, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412676463
    PMA / PMN Number
    K201867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED; HOWEVER, REVIEW OF THE EVENT HISTORY LOG FILES ASSOCIATED WITH HOMECHOICE CLARIA CYCLER WERE REVIEWED. A REVIEW OF THE MOST RECENT THERAPY REVEALED THE PATIENT PERFORMED A MANUAL DRAIN OF 3928ML AFTER RECEIVING 2200ML DURING FILL 1 OF 2. A REVIEW OF THE DEVICE PROGRAMMING REVEALED THE PROGRAMMED I-DRAIN ALARM (0ML) MAY HAVE BEEN SET TOO LOW FOR THE MOST RECENT TREATMENT. PER THE HOMECHOICE CLARIA APD SYSTEM PATIENT AT-HOME GUIDE, THE PROGRAMMED MINIMUM I-DRAIN VOLUME SHOULD BE SET TO AT LEAST 70% TO 95% OF THE PROGRAMMED LAST FILL VOLUME. BASED ON THE DEVICE LOG ANALYSIS, THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE THE PROGRAMMED MINIMUM I-DRAIN VOLUME BEING SET TOO LOW, USE ERROR. 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 FEELING FULL AND DIFFICULTY BREATHING DURING DWELL 1 OF 2. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO STOP THERAPY AND PERFORM A MANUAL DRAIN. THE PATIENT REPORTED THEY FELT BETTER AFTER DRAINING. IT WAS REPORTED THE DEVICE DRAINED 3928ML. 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668495 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412676463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other NI.