BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3190004 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16437
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES. THE DEVICE WAS RUN ON A LAB HOMECHOICE (HC) MACHINE WITH NO ISSUES. THE REPORTED ISSUE COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE BE RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS, A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING USE WHILE THE PATIENT WAS CONNECTED. THE PATIENT LINE HAD BEEN PROPERLY PRIMED AND NO PATIENT EXTENSIONS WERE IN USE. THE HOME PATIENT (HP) HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE BAGS WERE PROPERLY CONNECTED AND THERE WERE NOT ANY OPEN CLAMPS ON ANY UNUSED LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE HP STATED THERE WERE NO OBVIOUS REASONS FOR THE SYSTEM ERROR 2240. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND REMOVE THE CASSETTE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290423 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE