BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1831318 · Received September 10, 2010

    Report

    Report Number
    1423500-2010-03347
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF AIR IN LINE. THE REPORT WAS NOT CONFIRMED. BASED UPON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE AIR IN TUBING WAS USER ERROR. THE CAREGIVER STATED HE CONNECTED BEFORE PRIMING WAS COMPLETE. SINCE THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE PATIENT AT HOME GUIDE INSTRUCTS USERS WHEN AND HOW TO PRIME THE CASSETTE, TO OPEN THE PATIENT LINE CLAMP FOR PRIMING, AND WARNS TO NOT CONTINUE THERAPY AFTER PRIME UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REQUESTING ASSISTANCE TO END THERAPY ON THE HOMECHOICE (HC) MACHINE DURING FILL 1. THE CG STATED THAT HE DID NOT HAVE THE PATIENT LINE CLAMP OPEN DURING THE PRIME CYCLE AND STARTED THE THERAPY. THE CG STATED THAT THE HC DRAINED VERY LITTLE THEN STARTED FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO CHECK SETTINGS; THE INITIAL DRAIN ALARM = 0 ML AND LAST FILL VOLUME = 1000 ML. THE CG STATED THAT THE PATIENT LINE WAS FILLED WITH AIR. THE TSR ASSISTED THE CG TO END THERAPY TO RESTART THE SETUP WITH ALL NEW SUPPLIES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR