BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3812127 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15507
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AIR IN THE PATIENT LINE, INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE, WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) OBSERVED AIR IN THE PATIENT LINE (WITHOUT AN ALARM) DURING THE INITIAL DRAIN OF PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC) DEVICE, WHILE THE HP WAS CONNECTED. NOTHING WAS FOUND DURING TROUBLESHOOTING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN ENDING THERAPY AND ADVISED THE HP TO START THERAPY OVER USING NEW SUPPLIES. THE TSR REMINDED THE HP OF THE IMPORTANCE OF CHECKING THE PATIENT LINE FOR A COMPLETE PRIME AND REPRIMING IF NEEDED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290038 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE