BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2110846 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06936
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE IS UNKNOWN; THEREFORE, THE 510K NUMBER IS UNKNOWN. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE RN TO CLOSE ALL CLAMPS AND TRANSFER SET, AND TO CYCLE POWER TO CLEAR THE ALARM. THE TSR EXPLAINED THE ALARM INDICATED AIR ENTERED THE SET UP. THE HOME PATIENT (HP) CONFIRMED THERE WERE NO WET LINES AND HE/SHE DID NOT DISCONNECT PRIOR TO THE ALARM. THE HP ALSO CONFIRMED SPARE LINE CLAMPS WERE CLOSED. THE RN STATED THE HP DID DISCONNECT TO MAKE THE CALL TO BAXTER. THE RN CONFIRMED TO REPORT ALARMS TO PERITONEAL DIALYSIS RN THE FOLLOWING MORNING. THE HP CONFIRMED TO FINISH THERAPY MANUALLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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