BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3854335 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18244
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE SAMPLE WAS RECEIVED WITH A WHITE SOLUTION INSIDE THE FLUID PATH; THE WHITE RESIDUES ADHERED TO THE FLUID PATH. VISUAL INSPECTION REVEALED BURST TUBING. THE WHITE RESIDUE WAS DETERMINED TO HAVE BEEN FROM THE MEDICATION BEING USED AT THE TIME OF THE EVENT. A LABELING REVIEW WAS PERFORMED AND REVEALED THAT THIS SET IS NOT RATED FOR POWER INJECTION. THE CAUSE OF THE BURST RUPTURE CONDITION WAS DETERMINED TO BE USE ERROR. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A ONE-LINK CATHETER EXTENSION SET BURST DURING INFUSION OF AN UNKNOWN CONTRAST AGENT. IT WAS REPORTED THAT THE IV CONTRAST WAS RUN WITH A POWER INJECTOR FOR APPROXIMATELY THREE MINUTES AT "HALF THE NORMAL PRESSURE" WHEN THE TUBING BURST NEAR THE MALE LUER, LEADING TO CONTRAST AGENT SPRAYING ON THE TECHNICIAN AND THE PATIENT. THE TUBING WAS CLAMPED TO STOP THE FLOW. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333162 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR14B26054

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST AGENT| POWER INJECTOR