BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3130119 · Received May 21, 2013

    Report

    Report Number
    1828100-2013-00482
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED THROUGH DATA LOG ANALYSIS. LABORATORY ANALYSIS INCLUDED BENCH TESTING WITH PRESSURE SIMULATORS AND ENSURING ACCURATE READINGS AND ALERT! ALARM LEVELS WERE RESPONDED TO CORRECTLY. THE DEVICE PASSED AUTOMATED FUNCTIONAL TESTING AND INTERNAL INSPECTION REVEALED NO ANOMALIES. THE DATA LOGS INDICATE THERE WERE HIGH PRESSURE EVENTS, BUT THERE WAS NO EVIDENCE OF THE MODULE OR SENSORS MALFUNCTIONING. THE DATA LOGS INDICATE HIGH PRESSURE READINGS WERE CAUSED BY ACTUAL HIGH PRESSURE EVENTS. NO PRODUCT DEFICIENCY WAS IDENTIFIED SINCE PRODUCT MET MANUFACTURING SPECS AND PERFORMED TO INTENDED USE. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RELATED TO MDR #1828100-2013-00503.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: CLINICAL REVIEW PERFORMED ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    PER THE CLINICAL REVIEW: THE CARDIOVASCULAR (CV) TEAM USED A RECIRCULATING TYPE OF CARDIOPLEGIA SYSTEM THAT HAD A SURGEON DIRECTED ROUTE OF DELIVERY CONTROL DEVICE IN THE OPERATIVE FIELD. THIS ALLOWED AND REQUIRED THE CV SURGEON TO CONTROL/ALTER STOPCOCK POSITION TO DIRECT THE CARDIOPLEGIA SOLUTION TO A VARIETY OF CANNULAE: ANTEGRADE, RETROGRADE, VEIN GRAFT. TWO PRESSURES WERE BEING MONITORED/MEASURED IN TH CARDIOPLEGIA SYSTEM, WITH ONE SITE IN THE CARDIOPLEGIA KIT (MOUNTED ON SYSTEM-1) AND THE SECOND IN THE SURGICAL FIELD NEAR CANNULAE. THE CARDIOPLEGIA PUMP WAS CONNECTED (VIA SAFETY CONNECTION) TO BOTH OF THESE PRESSURES. THE INITIAL DOSE OF CARDIOPLEGIA WAS GIVEN WITHOUT ISSUE AND WAS GIVEN BOTH IN ANTEGRADE AND RETROGRADE FASHION. THIS PROVIDED INITIAL CARDIAC ARREST AND COOLING. A MAINTENANCE DOSE OF CARDIOPLEGIA WAS ALSO GIVEN, WITHOUT ISSUE AND WAS DELIVERED ANTEROGRADE, RETROGRADE, AND VIA A VEIN GRAFT. DURING DELIVERY OF THE THIRD DOSE, A HIGH PRESSURE ALARM WAS EXPERIENCED AND THE CARDIOPLEGIA ROLLER PUMP STOPPED (AS CONFIGURED). TROUBLESHOOTING OF THE HIGH PRESSURE CAUSE (IE: OBSTRUCTION IN THE SYSTEM) WAS COMMENCE AND NEITHER THE PERFUSIONIST (CCP) OR THE CV SURGEON WERE ABLE TO IDENTIFY A CIRCUIT OBSTRUCTION. CARDIOPLEGIA DELIVERY AGAIN WAS ATTEMPTED AND A HIGH PRESSURE ALARM (WITH PUMP STOP) AGAIN WAS EXPERIENCED. THE CCP WAS ABLE TO RE-ZERO ONE OF THE PRESSURE TRANSDUCERS BY OPENING THE TRANSDUCER TO ATMOSPHERE AND HE THUS FELT THE TRANSDUCER AND MODULE WAS WORKING ADEQUATELY. AGAIN, DELIVERY OF CARDIOPLEGIA WAS ATTEMPTED AND THE PRESSURE ROSE TO 625MMHG IN THE CARDIOPLEGIA SYSTEM AND THIS APPEARED TO DAMAGE THE CARDIOPLEGIA SYSTEM. THE CCP WAS IN THE PROCESS OF CHANGING OUT THE CARDIOPLEGIA DISPOSABLE KIT (IN ORDER TO BE ABLE TO ADMINISTER ANOTHER DOSE) AND THE CV SURGEON ELECTED TO UN-CLAMP THE AORTA AND PERFUSE THE HEART WITH OXYGENATED BLOOD. THE PROCEDURE WAS ABLE TO BE COMPLETED, AS SCHEDULED, AND THE PT WAS WEANED FROM CPB WITHOUT ISSUE. THE CCP ESTIMATED THE SURGICAL PROCEDURE WAS DELAYED BY TEN MINUTES AS THE HIGH PRESSURE EVENTS WERE BEING INVESTIGATED. IN THE END, THE CCP IS OF THE OPINION THAT A CLAMP WAS IN PLACE IN THE OPERATIVE FIELD AND THIS CAUSED THE HIGH PRESSURES IN THE CARDIOPLEGIA SYSTEM. EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PERFUSION SYSTEM WAS UNABLE TO DELIVER CARDIOPLEGIA DOSAGES. THE DEVICE WAS NOT CHANGED OUT, AS THE USER CALIBRATED ANOTHER MFR'S DISPOSABLE SENSOR TO AIR AND FINISHED CASE. THERE WAS A DELAY OF TEN MINUTES TO CHANGE OUT THE SENSOR. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413930 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DISPOSABLE PRESSURE SENSOR.