BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2100588 · Received May 13, 2011

    Report

    Report Number
    1828100-2011-01313
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 13, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT A LOW PRESSURE ALARM CAME ON WHEN TRYING TO CALIBRATE. THE USER COULD NOT ADJUST THE FLOW ON THE CENTRAL CONTROL MONITOR AND THEY PROCEEDED WITH THE CASE USING THE ELECTRONIC PATIENT GAS SYSTEM MANUALLY. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE GAS MODULE DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1