BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4202557 · Received September 18, 2014

    Report

    Report Number
    1828100-2014-00772
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NO YET CONCLUDED. THE SOFTWARE DATA LOGS WERE RECEIVED BY THE MANUFACTURER ON 08/28/2014. THE FIELD SERVICE REP (FSR) REPLACED THE EPGS AND THE SYSTEM OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT EPGS WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A "GAS SYSTEM NOT WARMING" ERROR MESSAGE ON THE ELECTRONIC PT GAS SYSTEM. THE LIGHT EMITTING DIODE (LED) WAS RED ON THE FRONT OF THE GAS SYSTEM. THE EPGS WOULD NOT CALIBRATE. AS A RESULT, AN ALTERNATE SYSTEM-1 WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580092 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (EPGS) DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801188

    Patients

    Seq Age Sex Outcome Treatment
    1