BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4002398 · Received July 9, 2014

    Report

    Report Number
    1828100-2014-00569
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFUSIONIST (CCP) CALLED THE FIELD SERVICE REPRESENTATIVE (FSR) DIRECTLY AND REPORTED THE ISSUE. THE CCP INSTALLED A NEW TEMPERATURE CABLE WITH NO CHANGE. THE FIELD SERVICE REPRESENTATIVE (FSR) HAD THE CCP SWAP THE ARTERIAL AND VENOUS TEMPERATURE CABLES IN THE MODULE AND THE PROBLEM FOLLOWED THE ARTERIAL CABLE. THE FSR EXPLAINED THE MODULE WAS WORKING CORRECTLY. THE CCP TRIED A SECOND NEW TEMPERATURE CABLE AND STILL HAD ISSUES. AFTER TROUBLESHOOTING WITH THE SALES ASSOCIATE, IT WAS DETERMINED THE ISSUE WAS WITH THE OXYGENATOR. THIS SYSTEM-1 WAS ONLY ON STAND-BY FOR THIS CASE. THE FSR REPORTED THAT THE TEMPERATURE MODULE WAS OPERATING TO MFR SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TEMPERATURE MODULE ON SYSTEM-1 FAILED DURING MORNING SET-UP. THE PERFUSIONIST (CCP) EXPLAINED THE ARTERIAL TEMPERATURE WAS READING DASHES "---" OR "999". THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399063 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802114

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO OXYGENATOR