BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1060953 · Received June 13, 2008

    Report

    Report Number
    1423500-2008-00492
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 24, 2008
    Report Date
    May 24, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SAMPLE ANTICIPATED; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED FULLNESS AND ABDOMINAL BLOATING AFTER USE OF THE HOMECHOICE SYSTEM FOR AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE HP REPORTEDLY ENCOUNTERED CHECK PATIENT LINE AND SLOW FLOW ALARMS DURING APD THERAPY, WHICH THE HP'S MOTHER DETERMINED WERE DUE TO THE HP LAYING ON THE PATIENT LINE OF THE HOMECHOICE SET. THE HP'S MOTHER HAD THE HP REPOSITION, WHICH UNKINKED THE LINE AND CLEARED THE ALARMS FROM THE SYSTEM. THE APD THERAPY CONTINUED TO COMPLETION WITHOUT FURTHER ALARMS AND THE HP DISCONNECTED AT AROUND 9AM. THE HP DID NOT FEEL ANY FULLNESS AT THAT TIME. AT AROUND 12:00 PM, THE HP FELT FULLNESS AND ABDOMINAL BLOATING. THE HP WANTED TO MANUALLY DRAIN; HOWEVER, NO CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) SUPPLIES WERE AVAILABLE. THE TSR VERBALLY ASSISTED THE CALLER TO SETUP THE HOMECHOICE SYSTEM AND A MANUAL DRAIN WAS PERFORMED WITH THE CYCLER. THE HP MANUALLY DRAINED 805MLS, WHICH WAS 605MLS GREATER THAN THE LAST FILL VOLUME RECEIVED OF 200MLS. THE TSR ASSISTED THE HP TO END THE HOMECHOICE THERAPY THEN SETUP THE SYSTEM IN ANTICIPATION OF APD THERAPY LATER THAT NIGHT. THE HP'S CYCLER WAS SUBSEQUENTLY REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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