BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2090424 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-06037
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED. 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, (B)(6) 2011, THE HOMECHOICE MACHINE ALARMED THE SYSTEM ERROR 2240 (AIR IN LINE) ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH A REPRESENTATIVE WHO STATED THAT THE HOME PATIENT (HP) HAD CALLED BACK AND STATED HE WAS HAVING PROBLEMS WITH PHONE AND WAS UNABLE TO SPEAK WITH THE TSR. THE ENGINEER CONTACTED THE HP LATER ON THE SAME DAY AND FOUND THAT THE PATIENT HAD ALREADY CLEARED THE ERROR. 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