BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3863541 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18492
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. HOWEVER, AN OPEN CLAMP ON AN UNUSED SUPPLY LINE WAS REPORTED AND IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY AND INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. THE GUIDE ALSO INSTRUCTS THE USER TO CLOSE ALL CLAMPS AT THE END OF THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM ON THE HOMECHOICE DEVICE DURING DWELL 1 OF 5 OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE POWER WAS CYCLED TO CLEAR THE ALARM AND PROPER PROCEDURES WERE REVIEWED WITH THE PATIENT. THE PATIENT WAS ADVISED TO START THERAPY OVER USING NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337760 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE