BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4182548 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36377
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AFTER REVIEW, THE CAUSE OF THE REPORTED EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT RECEIVED A HIGH DRAIN 101 (NIGHT DRAIN CYCLE ONE) ALARM ON THE HOME CHOICE DEVICE. A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE ALARM OCCURRED DURING DRAIN ONE OF PERITONEAL DIALYSIS THERAPY. THE TOTAL FILL VOLUME EQUALED 9200ML, THE TOTAL DRAIN VOLUME EQUALED 13923ML, THE CYCLE ONE ULTRAFILTRATION EQUALED 3456ML, AND THE LARGEST PRESCRIBED FILL VOLUME EQUALED 2300ML. TROUBLESHOOTING WAS ABLE TO DETERMINE THE HOME PATIENT PERFORMS A LAST FILL OF 2300ML AND THE INITIAL DRAIN VOLUME ALARM IS SET TO ZERO. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM AND ADVISED THE HOME PATIENT TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE REGARDING THE INITIAL DRAIN VOLUME ALARM. IT IS UNKNOWN HOW THE HOME PATIENT COMPLETED 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
    660504 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR