BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2111972 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-07018
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE REQUESTED. A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, 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

    REPORTEDLY ON (B)(6) 2011, THE HOMECHOICE (HC) MACHINE SOUNDED A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING DWELL 3 OF 4. 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 AND THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO RECYCLED POWER. THE TSR EXPLAINED THE ALARM AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES OR MANUAL EXCHANGE. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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