BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3843060 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17627
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A CLAMP BEING LEFT OPEN ON UNUSED LINES IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY WHEN PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THE GUIDE INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 ALARM (AIR IN SET) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING USE. THE HOME PATIENT (HP) INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THEY HEARD THE ALARM THE PREVIOUS NIGHT AND HAD LEFT AN UNUSED LINE CLAMP OPEN. THE HP HAD DISCONNECTED WHEN THEY SPOKE TO THE TSR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322260 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR HOMECHOICE