BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3062471 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09470
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. PER BAXTER LABELING, USERS ARE INSTRUCTED THAT CLAMPS ON ANY LINES MUST BE CLOSED WHEN DISCONNECTING FROM THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THERE WERE OPEN CLAMPS ON THE UNUSED SUPPLY LINES. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED THE PROPER SETUP PROCEDURE WITH THE HOME PATIENT (HP). THE HP WOULD SETUP WITH ALL 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
    163126 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE