BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3031463 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08144
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER BAXTER LABELING, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. THERE WERE OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE USED AND WERE CONNECTED PRIOR TO PRIMING. THE PATIENT DID NOT DISCONNECT ANYTIME PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. THE HOME PATIENT (HP) WOULD COMPLETE THERAPY WITH NEW SUPPLIES. 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
    134295 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR HOME CHOICE