BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4250455 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40397
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. HOWEVER, A CLAMP BEING LEFT OPEN ON UNUSED LINES AND CONNECTION PATIENT LINE EXTENSIONS AFTER PRIME ARE KNOWN CAUSES OF THIS ALARM. USE ERROR 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 INSTRUCTS USERS TO MAKE SURE THAT ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY AND TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. THE GUIDE ALSO WARNS THAT A SYSTEM ERROR 2240 CAN BE CAUSED BY UNCLAMPED, UNUSED SUPPLY LINES. FINALLY, THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND SAYS TO CONNECT PATIENT LINE EXTENSIONS BEFORE PRIME AND TO ALSO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. A 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 A HOMECHOICE (HC) DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET). THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING THE INITIAL DRAIN PHASE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT AN UNUSED SUPPLY LINE CLAMP WAS LEFT OPEN. THE CARE GIVER ALSO STATED THAT THEY USED PATIENT LINE EXTENSIONS BUT THEY DID NOT CONNECT THE EXTENSIONS BEFORE PRIMING. THE TECHNICAL SERVICES REPRESENTATIVE ASSISTED THE CARE GIVER TO CLEAR THE ALARM AND REVIEWED PROPER PROCEDURES WITH THE PATIENT. THE PATIENT WOULD COMPLETE THERAPY BY STARTING OVER WITH NEW SUPPLIES. THERE WAS NO 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
    738494 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE