BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4243415 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39894
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE HOMECHOICE MACHINE WAS IDENTIFIED. THE DEVICE WAS RECEIVED FOR ANALYSIS AND AN EVALUATION IS UNDERWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. A VISUAL INSPECTION WAS PERFORMED. THE REPORTED IIPV EVENT WAS IDENTIFIED IN THE EVENT HISTORY LOG, BUT NO NON-CONFORMING PRODUCT WAS FOUND DURING SAMPLE ANALYSIS THAT WAS RELATED TO THE REPORTED PROBLEM. REVIEW OF THE SERVICE HISTORY REVEALED THAT PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE PROVIDES A WARNING "IF YOU SET THE MINIMUM DRAIN VOLUME % TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A HIGH DRAIN ALARM AFTER THERAPY ON A HOMECHOICE MACHINE. A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE TECHNICAL SERVICE REPRESENTATIVE ARRANGED TO SWAP THE DEVICE AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725696 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXTRANEAL