BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3221403 · Received July 11, 2013

    Report

    Report Number
    1416980-2013-18052
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H12L15042 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TROUBLESHOOTING FOR THE UNRELATED ALARM THE REGISTERED NURSE (RN) NOTICED AIR IN THE PATIENT LINE DURING THE INITIAL DRAIN, WHILE THE HOME PATIENT (HP) WAS CONNECTED. DURING TROUBLESHOOTING NOTHING UNUSUAL WAS FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE RN CLOSE THE CLAMPS, DISCONNECT THE HP AND CYCLE THE POWER. THE TSR ASSISTED THE RN WITH ENDING THE THERAPY. 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
    319929 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12L15042

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR HOMECHOICE