BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1903852 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06062
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE PATIENT STATED THERE WAS AIR IN THE LINE BUT IT WAS FULLY PRIMED BEFORE SHE CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT IF THERE WAS AIR IN HER TRANSFER SET OR CATHETER IT WAS PULLED INTO THE LINE. FROM THE DATA WITHIN THE COMPLAINT INFORMATION THE ROOT CAUSE WAS NOT IDENTIFIED. 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 HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK PATIENT LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED THERE WAS AIR IN THE LINE AGAIN, BUT IT WAS FULLY PRIMED BEFORE SHE CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT IF THERE WAS AIR IN HER TRANSFER SET OR CATHETER IS WAS PULLED OUT INTO THE LINE. THE TSR EXPLAINED THAT THE AIR IS STILL A PROBLEM AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HP STATED SHE WAS ON VACATION AND WAS ON VACATION. THE TSR ASSISTED WITH ENDING THERAPY AND THE HP WOULD CONTACT THE NURSE AND ASK IF IT WAS OK TO SKIP A DAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER 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 62 YR