BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2760802 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00736
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K121634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE REPORTED CONDITION OF A LEAK COULD NOT BE CONFIRMED AS SAMPLES WERE NOT AVAILABLE. A ROOT CAUSE ALSO COULD NOT BE IDENTIFIED DUE TO SAMPLE UNAVAILABILITY. A BATCH REVIEW WAS PERFORMED FOR THE COMPLAINT LOT. THE BATCH REVIEW REPORTS NO MANUFACTURING ABNORMALITIES AND LOT WAS DETERMINED TO BE WITHIN MANUFACTURING SPECIFICATIONS. IF SAMPLES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE (BSR) NOTIFIED BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) OF ONE CLEARLINK SYSTEM EXTENSION SETW/CONTROL-A-FLO REGULATOR IN WHICH THE CONTROL-A-FLO PORTION CAME APART. A NURSE WAS PUSHING ADENACARD IN THE LOWEST PORT WHILE ANOTHER NURSE WAS PUSHING A SALINE FLUSH AT THE NEXT PORT UP WHEN THE CONTROL-A-FLO CAME APART. THE PATIENT WAS ABLE TO RECEIVE ANOTHER DOSE OF ADENACARD. THERE WAS NO PATIENT INJURY 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 - AIBONITO UR12F27014

    Patients

    Seq Age Sex Outcome Treatment
    1 ADENACARD, SALINE