BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3813202 · Received March 26, 2014

    Report

    Report Number
    1828100-2014-00194
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. SOFTWARE DATA LOGS WERE RECEIVED BY THE MANUFACTURER ON 03/04/2014. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED FUNCTIONAL AND RELEASE TESTING ON THE SYSTEM AND WAS UNABLE TO VERIFY THE MALFUNCTION OF THE EPGS. THE FSR REPLACED THE EPGS AS A PRECAUTION, PERFORMED FUNCTIONAL AND RELEASE TEST. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT EPGS SYSTEM WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) DISPLAYED NINE LITERS OF FLOW ON CENTRAL CONTROL MONITOR (CCM) AND EXTERNAL FLOW METER. PER THE PERFUSIONIST (CCP), THEY WERE UNABLE TO SEE CLINICAL EFFECTS. THERE WAS A ONE HOUR DELAY. AS A RESULT, AN ALTERNATE SYSTEM WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176869 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (EPGS) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention MECHANICAL GAS FLOWMETER| CDI 500 BLOOD PARAMETER MONITOR| TERUMO TUBING PACK| RADIOMETER BLOOD/GAS ANALYZER