BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.V. EXTENSION SET 7-SL

    MDR report key: 464173 · Received June 2, 2003

    Report

    Report Number
    9613251-2003-00080
    Event Type
    Malfunction
    Date Received
    June 2, 2003
    Date of Event
    May 1, 2003
    Report Date
    May 8, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN EXTENSION SET THAT "BURST" DURING A POWER INJECTION OF CONTRAST MEDIUM. THE CUSTOMER REPORTED THAT THE POWER INJECTOR WAS CONNECTED TO A "LONG CURLY" EXTENSIOIN SET MANUFACTURED BY EZ-M. CONNECTED DISTALLY TO THE EXTENSION SET WAS ANOTHER TUBING SET, A 7-INCH MACROBORE EXTENSION SET MANUFACTURED BY ABBOTT. THE TUBING SET UP WAS CONNECTED TO THE PATIENT'S PERIPHERAL IV LINE. DURING A CT SCAN PROCEDURE TO RULE OUT A PULMONARY EMBOLUS, THE CONTRAST WAS INJECTED USING THE POWER INJECTOR AT 2CC/SECOND, WITH AN UNSPECIFIED PSI. THE ABBOTT EXTENSION SET WAS REPORTED TO HAVE "BURST" 10-12 SECONDS FROM THE START OF THE INJECTION. THE IV SITE REMAINED INTACT, AND THE TUBING SETUP WAS REPLACED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO MEDICAL INTERVENTION WAS REQUIRED. REPORTEDLY, THE CUSTOMER WAS AWARE PRIOR TO THE RPEORTED EVENT THAT THE EXTENSION SET IS NOT INDICATED FOR USE WITH A POWER INJECTOR. HOWEVER, IT WAS REPORTED THAT THE CUSTOMER HAS ROUTINELY USED THE POWER INJECTOR TO INFUSE CONTRAST MEDIUM. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I.V. EXTENSION SET 7-SL ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other EXTENSION SET (MANUFACTURED BY EZ-M).| POWER INJECTOR (MANUFACTURED BY MEDRAD).