BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PRIME LINES

    MDR report key: 1061970 · Received June 13, 2008

    Report

    Report Number
    1828100-2008-00300
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 12, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED FOREIGN MATTER IN THE CONNECTOR PREVENTING THE FLOW FO BLOOD. THE PROCEDURE WAS CONCLUDED WITHOUT INCIDENT. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PRIME LINES PRIMING TUBE 1/4 SINGLE DWF TERUMO CARDIOVASCULAR SYSTEMS CORP 11600 0498707

    Patients

    Seq Age Sex Outcome Treatment
    1