BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4202554 · Received September 18, 2014

    Report

    Report Number
    1828100-2014-00777
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE MANUFACTURER CLINICAL SPECIALIST SPOKE TO THE PERFUSIONIST (CCP) AFTER THE CASE AND ALSO VERIFIED THE ROLLER PUMP WAS TRACKING VOLUME. THE FSR VERIFIED THE ROLLER PUMP SETTINGS AND THAT IT WAS TRACKING VOLUME. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS PERFORMED TO CLINICAL USE. THE FSR DOWNLOADED THE DATA LOGS FOR FURTHER EVAL. 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 USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP WAS NOT TRACKING VOLUME. THE DEVICE WAS NOT CHANGED OUT, AS THEY CONTINUED TO USE THE PUMP. 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
    580091 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801041

    Patients

    Seq Age Sex Outcome Treatment
    1