BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET. FOR LBL. BLD. DERIVW LL

    MDR report key: 1842475 · Received September 23, 2010

    Report

    Report Number
    6000001-2010-03483
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED AND THEREFORE IS NOT AVAILABLE FOR EVALUATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6) 2010 AN INCIDENT WHERE THE ROLLER CLAMP WOULD NOT SHUT OFF WITH AN ADMINISTRATION SET. AT THE TIME OF THE INCIDENT IT WAS REPORTED THAT THE FLUID WOULD CONTINUE TO FLOW DESPITE THE ROLLER CLAMP BEING FULLY CLOSED. THIS CREATED THE POTENTIAL FOR A SERIOUS SITUATION AS THE THORACIC PATIENT RECEIVED 500 ML OF AN UNKNOWN MEDICATION AND THE NURSE THOUGHT THE DRIP WAS TURNED OFF. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIN SET. FOR LBL. BLD. DERIVW LL FPA BAXTER HEALTHCARE - MALTA 10F16V796

    Patients

    Seq Age Sex Outcome Treatment
    1