BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2933657 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02170
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS. A PRESSURE TEST WAS PERFORMED, AND NO FAILURES WERE OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER CANADA TO REPORT A CLEARLINK SET IN WHICH THE FACILITY WAS HAVING A PROBLEM WITH THE SET'S TUBING. ACCORDING TO THE FACILITY, THE TUBING IS CRACKING, RESULTING IN BLOOD BACKFLOWING INTO THE TUBING AND OUT ONTO THE BED. THE MALFUNCTION WAS REPORTED TO HAVE BEEN FOUND DURING INFUSION. THERE WAS A PATIENT INVOLVED; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39206 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12H01023

    Patients

    Seq Age Sex Outcome Treatment
    1