BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4120897 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33317
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 IS A KNOWN CAUSE 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. FINALLY THE GUIDE WARNS THAT A SYSTEM ERROR 2240 CAN BE CAUSED BY UNCLAMPED, UNUSED SUPPLY LINES. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN SET/LINE). THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM DURING INITIAL DWELL FOUR OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT AN UNUSED SUPPLY LINE CLAMP WAS LEFT OPEN. THE PATIENT STATED THAT THEY WOULD COMPLETE THERAPY USING MANUAL 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
    601998 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE