BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 16057526 · Received December 27, 2022

    Report

    Report Number
    1416980-2022-07078
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    November 28, 2022
    Report Date
    January 23, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412094564
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER LAST NAME: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO B5: DURING FOLLOW UP, IT WAS CLARIFIED THE PATIENT DID NOT PROPERLY CONNECT THE SOLUTION BAG TO THE SUPPLY LINE (PREVIOUSLY OMITTED). CORRECTION MADE TO F10/H6: MEDICAL DEVICE PROBLEM CODES: A2303 ADDED (PREVIOUSLY OMITTED). USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN THE "HOMECHOICE CLARIA APD SYSTEM PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE CLARIA DEVICE. THE GUIDE INSTRUCTS THE USER TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. ALSO, IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY CONNECTING THE PATIENT LINE TO THE TRANSFER SET. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOMECHOICE CLARIA DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM; A LEAK OCCURRED. THE PATIENT WOULD SETUP WITH NEW SUPPLIES. 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
    2050627 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H22B23077 00085412094564

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female CLEARFLEX PHYSIONEAL 1,36 AND 2,27| HOMECHOICE CLARIA DEVICE