BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 976112 · Received December 10, 2007

    Report

    Report Number
    1423500-2007-01258
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Date of Event
    November 10, 2007
    Report Date
    November 10, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP WITH THE RN WILL BE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE SAMPLE AVAILABILITY AND CLARIFICATION OF THE DETAILS OF THE EVENT. ADDITIONAL PMA/510(K) #: K923065.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A HOME PATIENT (HP) FEELS TOO FULL IN DWELL 1 AND WANTS TO DRAIN OFF. TSR STOPPED THERAPY AND PLACED THE HP IN MANUAL DRAIN. THE HP DRAINED 2313ML AND FEELS BETTER. THE HP'S THERAPY PROGRAM IS AS FOLLOWS: CCPD/IPD TV=10L, TT=8HRS, FV=2200ML, LFV=1200ML, DEX=SAME, CYC=4, DT=1:20, I-DA=100ML, CC=36, LMD=N. THE LAST VOLUME INFUSED IN FILL 1 WAS 2200ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1