BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1850006 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03950
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR (SE) 2240 ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS NOT DETERMINED. 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 HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 3 OF 4. THE HP STATED HE HAD 3 BAGS CONNECTED. THE HP STATED HE WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE HP STATED ALL BAGS WERE PROPERLY SPIKED AND CONNECTED AND THERE WERE NO PATIENT EXTENSION LINES IN USE. THE HP CONFIRMED THERE WERE NO OPEN CLAMPS ON UNUSED SUPPLY LINES AND THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CYCLE POWER. THE HP CONFIRMED HE WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1