BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3802745 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14978
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) DEVICE, THE HOME PATIENT (HP) HAD AIR IN THE PATIENT LINE DURING INITIAL DRAIN. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE EVENT. THERE WAS NOTHING UNUSUAL FOUND DURING THE TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE REGISTERED NURSE (RN) TO END THE THERAPY AND START OVER WITH ALL NEW SUPPLIES FOR THE HP. 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
    280671 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR HOMECHOICE