BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3964424 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24549
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED ISSUE. A VISUAL INSPECTION WAS PERFORMED WITH NO ABNORMALITIES NOTED. LEAK TESTING, CLAMP FUNCTION TESTING, AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS RUN ON A LAB HOMECHOICE DEVICE WITH NO ISSUES. UPON CONCLUSION OF THE EVALUATION, THE RETURNED SAMPLE WAS DETERMINED TO MEET VISUAL AND FUNCTIONAL PRODUCT SPECIFICATIONS. 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 (SE) 2240 (AIR IN LINE/SET) ON THE HOMECHOICE (HC) DEVICE DURING DWELL 3 OF 5 OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HP WAS CONNECTED. NOTHING WAS FOUND DURING TROUBLESHOOTING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE CARE GIVER (CG). THE TSR THEN HAD THE CG CLOSE ALL OF THE CLAMPS, CYCLE THE POWER ON THE HC DEVICE, REMOVE THE CASSETTE, AND TURN OFF THE HC. THE CG WAS ADVISED TO HAVE THE HP START THERAPY OVER WITH 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
    440818 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE