BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2080462 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05609
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT CODE IS UNKNOWN THEREFORE A 510K NUMBER WILL NOT BE PROVIDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 4 OF 4. THE HOME PATIENT (HP) WAS CONNECTED TO THE HC. THE HP DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM, ALL BAGS WERE PROPERLY SPIKED AND CONNECTED, THE EXTENSION LINES WERE NOT USED AND THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES SUCH AS A LEAK. THE HP STATED HE WAS SEEING AIR IN THE PATIENT LINE STARTING NEAR THE TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER TO THE HC MACHINE, AND THEN SE 2367 ALARM OCCURRED. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE THE CASSETTE. THE HP WOULD NOTIFY THE PERITONEAL DIALYSIS NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE