BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3013196 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06715
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE DISPOSABLE CASSETTE WAS NOT RETURNED TO BAXTER FOR EVALUATION, A LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SYSTEM ERROR (SE) 2240 OCCUR DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING A HOMECHOICE IN CONJUNCTION WITH A DISPOSABLE CASSETTE. THE HOME PATIENT (HP) WAS CONNECTED AND IN DWELL 4 OF 6. THE HP STATED THAT SOLUTION WAS IN HEATER BAG ONLY, THE SUPPLY BAG IS EMPTY, AND THERE WAS NO DISCONNECTION FROM THE CASSETTE. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING, NO PATIENT EXTENSION LINES WERE USED, THE HP DID NOT DISCONNECT PRIOR TO THE ALARM, ALL BAGS WERE PROPERLY CONNECTED, THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES, AND THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM WITH THE HP AND ASSISTED THEM WITH TROUBLESHOOTING AND CLEARING THE ALARM. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116075 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE