BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1040662 · Received May 9, 2008

    Report

    Report Number
    1423500-2008-00329
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 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

    (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECH SVS CENTER REGARDING A POSSIBLE OVERFILL. THE HOME PT STATED THAT HE WAS FORCED TO END THERAPY AFTER THE FIRST CYCLE AFTER FEELING SYMPTOMS OF OVERFILL. THE HOME PT FELT ABDOMINAL PAIN, NAUSEA AND COULD FEEL FLUID IN HIS CHEST AREA. THE HOME PT SHUT OFF THE HOMECHOICE AND DISCONNECTED, THEN DID A MANUAL EXCHANGE TO DRAIN FLUID OUT. THE TECH SVS REP (TSR) REVIEWED THE ALARM LOG AND FOUND NO ALARMS THAT OCCURRED DURING THE PREVIOUS THERAPY. THE HOME PT'S FILL VOLUME WAS 2500 ML. THE PT DID NOT RECORD HIS DRAIN VOLUME BUT STATED THAT IT WAS LARGE. FOLLOW UP CONTACT WAS MADE WITH THE HOME PT. THE HOME PT STATED THAT HE WAS HAVING NO FURTHER PROBLEMS WITH THERAPY. NO FURTHER INFO REGARDING THIS EVENT COULD BE OBTAINED DESPITE REQUESTS FROM BAXTER. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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