BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1063835 · Received June 19, 2008

    Report

    Report Number
    1423500-2008-00515
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOME PATIENT DID NOT WANT TO RETURN THE HOMECHOICE MACHINE FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN OVERFILL WITH THE HOMECHOICE (HC) MACHINE IN FILL 3 OF 4. THE FILL VOLUME WAS AT 13 ML WHEN STOPPED BY THE CAREGIVER (CG). THE HOME PATIENT (HP) ALSO REPORTED ABDOMINAL DISCOMFORT. THE CG HAD DONE A MANUAL DRAIN OF 1370 ML BEFORE CONTACTING TECHNICAL SERVICES. THE TECHNICAL SVC REP (TSR) REVIEWED THERAPY INFORMATION AND DISCOVERED THE PREVIOUS DRAIN CYCLE (DRAIN 2) HAD ENDED WITH AN ULTRAFILTRATION UF READING OF 1091 ML. THIS UF INDICATES THAT THE HP DRAINED 1091 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2500 ML. THE DRAIN VOLUME IN DRAIN 2 WOULD HAVE BEEN 3591 ML. TWO MANUAL DRAINS WERE PERFORMED WITH THE TSR AND 190 ADDITIONAL ML WERE DRAINED. THESE TWO CYCLES COMBINED PROVIDE A FILL VOLUME OF 2513 ML AND A TOTAL DRAIN VOLUME (MANUAL DRAINS PLUS THE DRAIN 2 VOLUME) OF 5151 ML. THE CG REPORTED THE HP HAD BEEN RETAINING FLUID AS OF LATE AND WAS USING 4.25% DEXTROSE FOR THERAPY TO REMOVE EXCESS FLUID. IT WAS ALSO NOTED THAT THE HP HAS GAS WHICH MAY EFFECT HIS ABILITY TO DRAIN FULLY. THE HP'S NURSE REPORTED THE PT WAS DOING FINE, AND THERE HAVE BEEN NO OTHER PROBLEMS WITH THE HC MACHINE. THE NURSE BELIEVED THIS OVERFILL WAS AN ISOLATED INCIDENT AND THE MACHINE WAS WORKING FINE. NO ADJUSTMENTS HAVE BEEN MADE TO THE HP'S THERAPY SETTINGS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT ACCORDING TO THE HP'S NURSE.

    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 49 YR