BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 21426327 · Received February 20, 2025

    Report

    Report Number
    9612057-2025-00003
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 25, 2025
    Report Date
    March 18, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412522883
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW, THE REPORTED "SHORT CIRCUIT" WITH THE HOMECHOICE CLARIA WAS DETERMINED TO BE A POWER FAILURE. THE PATIENT CAN BEGIN/CONTINUE THERAPY WITH MANUAL SUPPLIES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS SHORT CIRCUIT WHILE USING A HOMECHOICE CLARIA. THIS OCCURRED DURING AN UNKNOWN PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029696 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412522883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown