BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1812952 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02826
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 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 IS UNKNOWN AT THIS TIME. SHOULD A SAMPLE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE OF THE EVENT WAS RELATED TO THE HOME PATIENT'S PET BITING THE TUBING LINE. A LABEL REVIEW WAS CONDUCTED AND FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. AFTER SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THE SAMPLE AVAILABILITY IS UNKNOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE ENDING THERAPY ON THE HOMECHOICE. THE HOME PATIENT (HP) STATED HER PET BIT THE PATIENT LINE. THE HP ALREADY CONTACTED HER NURSE AND WAS ADVISED TO END THERAPY EARLY AND FOLLOW-UP WITH A MANUAL EXCHANGE LATER IN THE DAY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROX 8 MONTHS POST XIENCE V STENT IMPLANTATION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY, DURING A ROUTINE F/U ANGIOGRAM, STENOSIS WAS NOTED AND ANOTHER STENT WAS PLACED OVERLAPPING THE XIENCE V STENT. THERE WAS NO ADVERSE PT SEQUELA. ON (B)(6) 2010, THE PT WAS DISCHARGED. NO ADDITIONAL INFO WAS PROVIDED.

    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 50 YR