BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2571653 · Received May 11, 2012

    Report

    Report Number
    6000001-2012-10310
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    January 5, 2012
    Report Date
    April 19, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE US DEPARTMENT OF HEALTH AND HUMAN SERVICES AND A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, DOXORUBICIN WAS INFUSING INTO A RIGHT UPPER ARM PERIPHERALLY INSERTED CENTRAL CATHETER. THERAPY WAS INITIATED AT 14:10 AND THE RATE WAS SET TO INFUSE AT 22CC/HOUR. THE REGISTERED NURSE (RN) RETURNED TO THE PATIENT'S ROOM AT 18:05 TO CHECK ON THE PATIENT, WHEN THE PATIENT INDICATED THAT THE DOXORUBICIN WAS LEAKING ONTO HIM. THE RN INSPECTED TO CLEARLINK SOLUTION SET, AND NOTICED THAT THE TAPE AT THE CLEARLINK SITE WAS WET. THE PATIENTS PILLOW AND GOWN WERE A PINK COLOR, WHICH WAS THE SAME COLOR AS THE MEDICATION. AFTER THE RN INSPECTED THE TUBING, IT WAS OBSERVED THAT THE LEAK OCCURRED FROM WHERE THE TUBING MEETS THE BACK PART OF THE CLEARLINK. THE RN INDICATED THAT THE CLEARLINK WAS IN CORRECTLY AND TIGHT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE AN UNKNOWN ADMINISTRATION SET IN WHICH A LEAK OCCURRED AT THE CONNECTION OF THE SECONDARY SET TO THE CLEARLINK ON THE Y-SITE. THE ALLEGED DEFECT OCCURRED DURING THE ADMINISTRATION OF AN UNKNOWN CHEMOTHERAPY MEDICATION ON A PATIENT. THE UNKNOWN CHEMOTHERAPY MEDICATION SPILLED ON TO THE FLOOR. THERE WAS NO CONTACT OF THE MEDICATION WITH THE NURSE OR THE PATIENT. THEREFORE, THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R11G21123

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR DOXORUBRICIN| UNKNOWN CHEMOTHERAPY MEDICATION