BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3130655 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13434
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 NOTED. THE DEVICE WAS RUN ON A LAB HOMECHOICE MACHINE WITH NO ISSUES. THE REPORTED ISSUE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAREGIVER (CG) SAW AIR BUBBLES IN THE PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO END THE THERAPY AND START OVER USING ALL NEW SUPPLIES. THE TSR ASSISTED THE CG TO END THE THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231602 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE