BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3140055 · Received May 29, 2013

    Report

    Report Number
    1828100-2013-00508
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REP (FSR). THE FSR INDICATED A WIRE INSIDE THE LEVEL SENSOR CABLE IS BROKEN. THE FSR INSTALLED A NEW LEVEL SENSOR ON THE SYSTEM. WITH THE SENSOR REPLACED, THE UNIT OPERATED TO MFR SPEC AND WAS RETURNED TO CLINICAL USE. IF ADD'L 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 ALERT LEVEL SENSOR INTERMITTENTLY FAILED. THE ISSUE HAD BEEN ONGOING FOR APPROX ONE MONTH. THE CUSTOMER HAD BEEN DRAPING THE WIRE IN A WAY THAT THE UNIT WOULD WORK. WHEN THE CABLE WAS NOT DRAPED JUST RIGHT, THEY WERE GETTING AN AUDIBLE TONE. THE DEVICE WAS NOT CHANGED OUT. 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
    234447 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195215

    Patients

    Seq Age Sex Outcome Treatment
    1