BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3183708 · Received June 22, 2013

    Report

    Report Number
    1416980-2013-16225
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE LOGS FOUND THAT DRAIN VOLUMES MET INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. DURING DEVICE EVALUATION, THE DEVICE PASSED HOMECHOICE RITE ELECTRICAL AND RITE FUNCTIONAL TESTING. THE EXTERNAL AND INTERNAL INSPECTIONS FOUND NO ISSUES. THE DEVICE HAD SUCCESSFULLY PASSED MULTIPLE SIMULATED THERAPIES. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCES TO THE NEXT FILL WHEN SLOW OR NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. NO FAILURE OR MALFUNCTION WAS IDENTIFIED WITH THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) RECEIVED A HIGH DRAIN 105 ALARM ON THE HOMECHOICE (HC) MACHINE DURING USE, WHILE THE HP WAS NOT CONNECTED. THE HIGH DRAIN ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO USE MANUAL SUPPLIES IN ORDER TO FINISH THE THERAPY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284225 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIABETES-RELATED MEDICATION