BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4250307 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40455
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED WITH NAKED EYE WITH NO ISSUES NOTED. FUNCTIONAL TESTS WERE PERFORMED ON THE DEVICE THAT INCLUDED LEAK TESTING, CLAMP FUNCTION TEST, CLEAR PASSAGE TEST, AND DEVICE-DEVICE INTERACTION WITH NO ISSUES NOTED. THE REPORTED PROBLEM WAS NOT VERIFIED. THE SAMPLE EVALUATION COULD NOT DUPLICATE THE REPORTED PROBLEM; THEREFORE THE CAUSE OF THE CONDITION IS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING THE DWELL CYCLE FOUR OF FIVE OF PERITONEAL DIALYSIS THERAPY. THERE WAS NOTHING UNUSUAL FOUND DURING TROUBLESHOOTING THAT WOULD CAUSE OR CONTRIBUTE TO THE ALARM. THE TECHNICAL SERVICES REPRESENTATIVE ASSISTED THE PATIENT TO CLEAR THE ALARM. THE PATIENT WOULD COMPLETE THERAPY BY USING MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736597 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14H21052

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE