BEUDAMED
    FDA Adverse Event Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3941772 · Received June 25, 2014

    Report

    Report Number
    1828100-2014-00539
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 1, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWB
    PMA / PMN Number
    K953901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. CLINICAL REVIEW ON (B)(4) 2014: DURING SETUP OF THE CPB CIRCUIT, THE PERFUSIONIST (CCP) NOTICED THAT WHEN THE ROLLER OCCLUSION WAS CHECKED AND ADJUSTED FOR THS PUMP (ARTERIAL PUMP), ONE ROLLER SEEMED TIGHTER THAN THE OTHER (VERY SMALL DROP IN PRESSURE COMPARED TO THE OTHER ROLLER). ABOUT SIXTY MINUTES INTO CPB, THE CCP NOTICED A SQUEAK AND CLICKING SOUND FROM THE ROLLER PUMP. ABOUT FIFTEEN MINUTES LATER, THE SOUND WAS MORE OF A "THUMPING SOUND". IN ANOTHER FIFTEEN MINUTES, OR SO, THE SOUND WAS MORE OF A "RUMBLING GROWL" SOUND. UP TO THIS POINT, THE PUMP SPEED OR RESULTANT FLOW WAS NOT IMPACTED. DURING WEANING OF THE PATIENT FROM CPB, WHEN THE PUMP SPEED WAS REDUCED AND THE FLOW PROVIDED WAS ABOUT 2 LITERS/MINUTE, THE CCP NOTICED A PULSE-LIKE BEHAVIOR OF THE ROLLER PUMP. THE PUMP WAS STILL FUNCTIONING AND THE PATIENT WAS ABLE TO BE SUCCESSFULLY WEANED FROM CPB. CPB WAS TERMINATED AND THE PATIENT HAD NO CLINICAL ISSUES AS A RESULT OF THE PUMP NOISE OR BEHAVIOR. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM OF THE PATIENT OBSERVED OR REPORTED. AFTER THE PROCEDURE, THE ENTIRE HEART-LUNG MACHINE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PERFUSIONIST (CCP) SAID THAT THE ROLLER PUMP HEAD STARTED TO "WHINE" HALF WAY THROUGH THE PUMP RUN. AS TIME WENT ON, THE ROLLER PUMP STARTED TO MAKE A "GRINDING" TYPE SOUND. ADDITIONALLY, THE PUMP HEAD STARTED TO PULSE, WITHOUT THE PULSATION BEING ACTIVATED. THE CCP DID TEST THE ARTERIAL PUMP HEAD AFTER REMOVING THE TUBING, AND IT DID FUNCTION WITHOUT THE HESITATION OR WHINING. IT APPEARED TO HAVE HAPPENED WHILE IT WAS UNDER PRESSURE. THE CCP DID KNOW THAT THE OCCLUSIONS WERE CHECKED PRIOR TO CPB, AND THEY APPEARED TO BE SET PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369778 TERUMO PERFUSION SYSTEM 8000 8K (PUMP, ROLLER TYPE) DWB TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1