BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3214010 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17840
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    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 WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT 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 SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING DRAIN 2 OF 3. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES, AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED WITH TROUBLESHOOTING TO IT. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313024 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR HOMECHOICE