BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE VOLUME I.V. ADMINISTRATION SET

    MDR report key: 1022754 · Received March 31, 2008

    Report

    Report Number
    2183502-2008-00068
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 29, 2008
    Manufacturer
    SMITHS MEDICAL MD, INC. (FORMERLY DELTEC, INC)
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. ONE USED ADULT BURETTE SET WAS RETURNED FOR SUSPECTED LEAKING AT THE UPPER ROLLER CLAMP OF THE SET. VISUAL EXAMINATION IDENTIFIED NO ABNORMALITIES OR DEFECTS. THE SET WAS HOOKED TO A STANDARD I.V. BAG, PLACED AT A STANDARD HEAD HEIGHT, AND GRAVITY PRIMED. THE CLAMP WAS FULLY SEATED TO THE FULLEST EXTENT OF THE ROLLER CLAMP AND THE BURETTE SET ASSEMBLY WAS LEFT UNTOUCHED FOR TWO AND ONE HALF HOURS. UPON INSPECTION AFTER THE ALLOTTED TIME, NO FLUID HAD GONE PASSED THE CLAMP. THE SET WAS PRESSURE TESTED PER MANUFACTURER'S SPECIFICATION FOR A ROLLER CLAMP ASSEMBLY. THIS STATES THAT THE ROLLER CLAMP MUST BE ABLE TO PERFORM WITHOUT LEAKAGE BEYOND THE CLAMP. DURING THE INITIAL VISUAL EXAMINATION IT WAS NOTED, THAT THE TOP ROLLER CLAMP WAS NOT FULLY CLOSED TO ITS FULLEST TRAVEL. THE ROLLER WAS APPROX 3/8" FROM THE FULL TRAVEL OF THE CLAMP. THE DEVICE WAS EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, THE CAUSE OF THE EVENT IS UNK. NO FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DESCRIBES AN INCIDENT THAT IS ALLEGED TO HAVE OCCURRED CONCERNING A LARGE VOLUME IV ADMINISTRATION SET WITH BURETTE THAT REQUIRED INTERVENTION. PER THE REPORT A BURETTE CONTAINING NORADRENALIN FILLED UP FROM THE BAG DESPITE THE (UPSTREAM) ROLLER CLAMP BEING CLOSED. THIS RESULTED IN OVERDILUTION OF NORADRENALIN WITH FLUID FROM THE 250ML BAG OF 5% GLUCOSE SOLUTION. A NEW INFUSION OF NORADRENALIN WAS SET UP AND THE PT'S BLOOD PRESSURE INCREASED. THERE WAS NO REPORT INCIDENT RELATED MEDICAL SEQUELAE. INITIAL TESTING BY THE USER FACILITY INVESTIGATING OFFICER REVEALED NO FAULT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE VOLUME I.V. ADMINISTRATION SET ADMINISTRATION SET FPA SMITHS MEDICAL MD, INC. (FORMERLY DELTEC, INC) 21-0318 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LARGE VOLUME INFUSION PUMP