BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3231114 · Received July 12, 2013

    Report

    Report Number
    1828100-2013-00664
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TUBE CLAMP ON THE ROLLER PUMP INTERMITTENTLY DOES NOT CLOSE. THIS HAS BEEN AN ONGOING ISSUE FOR THE CUSTOMER, DATE OF OCCURRENCE UNKNOWN. THE DEVICE WAS NOT CHANGED OUT. THE CUSTOMER WAS USING THE ROLLER PUMP FOR A STANDBY FOR AN OFF-PUMP CASE. THEY DID NOT HAVE TO USE THE SYSTEM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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
    322517 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801040

    Patients

    Seq Age Sex Outcome Treatment
    1