BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3802455 · Received February 21, 2014

    Report

    Report Number
    1828100-2014-00087
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE (FSR). THE FSR REPLACED THE OXYGEN (O2) SENSOR ON THE SYSTEM. THE EPGS OPERATED TO MANUFACTURER SPECIFICATION AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION 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 OXYGEN (O2) SENSOR WOULD NOT CALIBRATE ON THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE CUSTOMER USED ANOTHER SYSTEM FOR THE GAS (THEY DID NOT CHANGE OUT THE ENTIRE SYSTEM). THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110034 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (EPGS) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1