BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 18553631 · Received January 22, 2024

    Report

    Report Number
    1416980-2024-00115
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    December 30, 2023
    Report Date
    January 22, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED; HOWEVER, THE LOG FILES ASSOCIATED WITH THE CLARIA DEVICE WERE REVIEWED. A REVIEW OF THE DEVICE LOGS REVEALED THE PROGRAMMED MIN I-DRAIN VOLUME (0ML) WAS SET BELOW THE RECOMMENDED SETTINGS IN THE MOST RECENT THERAPIES. THE DEVICE LOGS INDICATED THE PATIENT FILLED WITH 2544ML DURING FILL 1 OF 7 AND THEN SUBSEQUENTLY INITIATED A MANUAL DRAIN OF 1536ML. THE PATIENT RESUMED THEIR THERAPY AND DRAINED 2633ML DURING DRAIN 1. PER THE HOMECHOICE CLARIA CLINICIAN GUIDE, THE PROGRAMMED MINIMUM INITIAL DRAIN SHOULD BE SET TO AT LEAST 70% OF THE EXPECTED PERITONEAL VOLUME. IF THE MINIMUM I-DRAIN VOLUME IS SET TO 0 (ZERO), IT CAN BE ASSOCIATED WITH A HIGHER RISK OF IIPV DUE TO THE POSSIBILITY OF AN INCOMPLETE DRAIN FOLLOWED BY A FULL FILL VOLUME. BASED ON THE DEVICE LOG ANALYSIS, THE DIRECT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE THE PROGRAMMED I-DRAIN ALARM 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 THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING BLOATED AND DIFFICULTY BREATHING DURING FILL 1 OF 7. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. IT WAS ALSO REPORTED THAT THE PATIENT SUSPECTED THAT THEY WERE NOT DRAINING ENOUGH. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO PERFORM A MANUAL DRAIN WHICH RELIEVED THE SYMPTOMS. THE PATIENT REPORTED THEY WERE ¿FEELING GOOD¿ AND WERE ¿GOOD¿ TO CONTINUE THERAPY. RTS ADVISED THE PATIENT TO CONTACT THE REGISTERED NURSE. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. 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
    1602433 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412676463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other