BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3900531 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20690
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).THE AFFECTED DEVICE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS VISUALLY INSPECTED AGAINST THE REPORTED CONDITION, VERIFYING THE PRESENCE OF THE AIR BUBBLES IN THE TUBING. TWO RESERVE SAMPLES FROM THE SAME LOT WERE AVAILABLE FOR EVALUATION. THESE SAMPLES WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE RESERVE SAMPLES SHOWED NO ABNORMALITIES AND PERFORMED ACCORDING TO THE DESIRED PRODUCT SPECIFICATIONS. THE REPORTED CONDITION COULD NOT BE VERIFIED THROUGH THE PHOTOGRAPHIC EVALUATION, AS THE PHOTOGRAPH DID NOT CONTAIN THE ENTIRETY OF THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBSERVING AIR BUBBLES IN A PATIENT'S FLOGARD IV ADMINISTRATION SET. THIS OCCURRED WHILE INFUSING TOTAL PARENTERAL NUTRITION AT 83ML/HR ON A CHANNEL C OF AN UNSPECIFIED BAXTER PUMP. THE CUSTOMER REPORTED THAT THE BUBBLES WERE APPROXIMATELY 0.1-0.3CM IN SIZE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377668 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 14A07V158

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER PUMP - CHANNEL C| TOTAL PARENTERAL NUTRITION