BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 19183554 · Received April 25, 2024

    Report

    Report Number
    1416980-2024-01901
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 4, 2024
    Report Date
    June 19, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412676463
    PMA / PMN Number
    K201867
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE SAMPLE ANALYSIS WAS PERFORMED AND THE DEVICE WAS FOUND TO MEET SPECIFICATIONS FOR THE REPORTED PROBLEM. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL TESTING OF THE DEVICE. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL SPECIFICATION REQUIREMENTS PER RITE TESTING. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.. THE SHARESOURCE LOG FILES ASSOCIATED WITH HOMECHOICE CLARIA WERE REVIEWED. THE REVIEW SHOWED THAT THERE WAS NO THERAPY DATA FROM 01-MAR-2024 TO 04-APR-2024 (REPORTED OCCURRENCE DATE). THERE WERE NO FINDINGS AVAILABLE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. BASED ON ADDITIONAL INFORMATION RECEIVED, HOMECHOICE CLARIA WAS DETERMINED NOT TO BE A FACTOR IN THE REPORTED ADVERSE EVENT. 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 (PD) PATIENT EXPERIENCED AN UNSPECIFIED CARDIAC EVENT DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. IT WAS FURTHER REPORTED THAT THE CYCLER THE PATIENT WAS USING AT THE TIME WAS A TRAINING CYCLER AT THE CLINIC. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855366 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA 00085412676463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other