BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1760707 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01524
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE ALARM WAS DUE TO THE PATIENT PLACING THE SOLUTION BAG ON AN UNSTABLE SURFACE AND THE SOLUTION BAG DISCONNECTED DURING THERAPY. THE RESULTS OF A LABEL REVIEW REVEALED THAT USERS ARE WARNED TO PLACE THE SOLUTION BAGS ON A FLAT, STABLE SURFACE AND TO NOT STACK BAGS. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE COMPLETED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR (SE) 2240 ALARM AND SE 2367 ALARM ON THE HOMECHOICE (HC) UNIT DURING DWELL 3/5. THE CAREGIVER (CG) STATED THAT A SUPPLY BAG FELL OFF OF THE TABLE AND CAME UNHOOKED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO CYCLE POWER. THE TSR ADVISED THE CG TO START OVER WITH NEW SUPPLIES TO CONTINUE THERAPY ON THE CYCLER FOR THE NIGHT. THE TSR ALSO ADVISED THE CG TO CONTACT THE PERITONEAL DIALYSIS NURSE (PDRN) ABOUT THE ALARM AND TO GET THERAPY ADVICE FOR THE NIGHT. THE CG CONFIRMED TO CALL THE PDRN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR