BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 903999 · Received August 23, 2007

    Report

    Report Number
    1423500-2007-01018
    Event Type
    Malfunction
    Date Received
    August 23, 2007
    Date of Event
    July 28, 2007
    Report Date
    July 28, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION, HOWEVER, THE HP WAS NOT INTERESTED IN AN EVALUATION OR SWAP OF THE DEVICE.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING FEELING OVERFILLED LAST NIGHT IN DRAIN 3. A REVIEW OF THE THERAPY LOG INDICATED THE FOLLOWING: IDV=0; LFV=0; TFV=6837; TDR 7334ML; AVG DWELL 2:09; AVG DWELL= :15; TUF= 497 UF/CYCLE 3=571; 2=32; 1=12; DF=-118; BYPASS=2. THE HP DRAINED A MAXIMUM OF 1200ML IN A MANUAL CAPD DRAIN. DIALYSIS THERAPY WAS CONTINUED USING THE CYCLER. THE PROGRAM PARAMETERS ARE AVAILABLE AND ARE AS FOLLOWS: HIDOSE CCPD; TV=7500; #DF=1; DFV=1000; NTT: 8:30; NFV=1500; LFV=0. NO INFORMATION WAS OBTAINED REGARDING THE PROGRAMMING OF THE DEVICE, THE TSR ADVISED THE HP TO CALL THE NURSE ABOUT THE OVERFILL. AN INITIAL DRAIN WAS BYPASSED AND PROPER BYPASS PROCEDURES WERE REVIEWED WITH THE HP. THE HP'S NURSE WAS CONTACTED AND STATED SHE WAS NOT AWARE OF THIS PARTICULAR INCIDENT, HOWEVER, THE HP OFTEN FEELS FULL (OFTEN AFTER EATING) AND THE NURSE IS AWARE OF IT. AFTER SPEAKING WITH THE NURSE, THE HP WAS CONTACTED ON THREE SEPARATE OCCASIONS WITH NO RESPONSE FROM THE HP. THE HP BYPASSED INITIAL DRAIN AT THE BEGINNING OF THERAPY AND THEREFORE DIDN'T DRAIN OUT THE 1000ML FROM DAY FILL, STARTED THERAPY AND LATER IN DRAIN 3 FELT OVERFILLED. CAUSE HAS BEEN IDENTIFIED AS THE HP NOT DRAINING OUT THE DAY FILL WHICH WOULD LEAD TO A FEELING OF OVERFILL WITH 1000ML OF EXTRA FLUID IN THE HP. THE NURSE WAS NOT AWARE OF ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 YR