BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3910741 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21327
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER DID NOT RECEIVE A SAMPLE FOR EVALUATION; HOWEVER A PHOTO WAS PROVIDED. THE PHOTOGRAPH INSPECTION SHOWED AIR IN THE TUBING HOWEVER THE CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED PHOTO. 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

    IT WAS REPORTED THAT A BUERETROL IV SOLUTION ADMINISTRATION SET WAS OBSERVED TO HAVE BUBBLES ¿IN THE SINGLE CHANNEL PUMP¿. THIS WAS IDENTIFIED DURING THE INFUSION OF VANCOMYCIN. THE INFUSION WAS DELIVERING AT A RATE OF 120 ML/HR. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387113 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13L19U227

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INFUSION PUMP| VANCOMYCIN