BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2140034 · Received June 25, 2011

    Report

    Report Number
    1423500-2011-08362
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED BY THE CUSTOMER. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT WHERE THE HOMECHOICE MACHINE ALARMED A SYSTEM ERROR (SE) 2240 DURING DWELL 9/10. THE PATIENT WAS CONNECTED TO THE MACHINE. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM. ALL BAGS WERE PROPERLY SPIKED AND CONNECTED. THERE WERE NO OPEN CLAMPS ON UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES, I.E. LEAKS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED HOME PATIENT THAT AIR HAD ENTERED SETUP. TSR HAD HP RECYCLE POWER. TSR ADVISED HP THERAPY HAD ENDED AND WILL NEED TO START OVER WITH NEW SUPPLIES OR DO MANUAL EXCHANGE. HP WILL DO MANUAL EXCHANGE. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE