BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2091981 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06115
    Event Type
    Malfunction
    Date Received
    May 18, 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). 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. SIMILAR REPORTS HAVE BEEN RECEIVED 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; 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.

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011, THE HOMECHOICE MACHINE SOUNDED A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING CYCLE 4 OF 4. THE PATIENT WAS CONNECTED TO THE MACHINE. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM. THERE WERE NO PATIENT EXTENSION LINES USED. THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THE HOME PATIENT (HP) HAD ALREADY CYCLED POWER TO CLEAR THE ALARM. THE HP HAD NO OTHER DETAILS. THE NURSE WAS ALREADY AWARE. THE ALARM CLEARED AND THERAPY ENDED PRIOR TO SPEAKING WITH THE TSR. 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