BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3915761 · Received June 12, 2014

    Report

    Report Number
    1828100-2014-00530
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 22, 2014
    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

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS CCM WAS RECENTLY IN FOR REPAIR (TOUCH SCREEN WAS NOT RESPONSIVE BUT NOT DUPLICATED, MDR #1828100-2013-00645). THE FIELD SERVICE REP (FSR) WAS UNABLE TO VERIFY THE CURSOR ON THE CCM WAS DRIFTING. THE FSR INSTALLED AND CONFIGURED A LOANER MONITOR, AND PERFORMED FUNCTIONAL TESTING. THE LOANER MONITOR OPERATED TO MFR SPECS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT DEVICE WAS RETURNED TO THE MFR FOR FURTHER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TOUCH SCREEN CURSOR ON THE CENTRAL CONTROL MONITOR (CCM) WAS DRIFTING. THE DEVICE WAS NOT CHANGED OUT, AS THE PERFUSIONIST (CCP) USED THE MANUAL CONTROLS AND CLAMPS TO OCCLUDE. 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
    346548 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1