BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 5538078 · Received March 31, 2016

    Report

    Report Number
    1828100-2016-00221
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 8, 2016
    Report Date
    June 15, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K151349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL EMDR SHOULD HAVE STATED THAT THE TEMPERATURE IN QUESTION WAS THE BLADDER TEMPERATURE IN THE BLUE CHANNEL, NOT THE MYOCARDIAL TEMPERATURE IN THE RED CHANNEL AS WAS INTIALLY REPORTED. THE REPORTED COMPLAINT WAS CONFIRMED. DATA LOG ANALYSIS SHOWED THAT ON (B)(6) 2016 THE TEMPERATURE MODULE WAS REPORTING TEMPERATURE STATUS CHANGE BETWEEN "IN RANGE" AND "UNDER RANGE" AND SOMETIMES DISCONNECTED ON CHANNEL 1 (BLUE CHANNEL AS REPORTED). IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. A SECOND PART WAS RECEIVED BY THE MANUFACTURER ON 23-MAR-2016 FOR FURTHER EVALUATION. THIS COMPLAINT IS RELATED TO EMDR #1828100-2016-00220. THE CCP TROUBLESHOT ON (B)(4) 2016 AND DETERMINED THERE WERE BAD CABLES CAUSING INTERMITTENT ¿---¿, SO SHE REPLACED. THE CCP REPORTS THE TEMPERATURE READINGS ARE MORE ACCURATE WHEN THE MODULES ARE PUSHED TIGHTER INTO NIC BOARD CONNECTIONS. THE TEMPERATURE IN QUESTION WAS THE MYOCARDIAL TEMPERATURE IN THE RED CHANNEL. THE FSR COULD NOT DUPLICATE THE REPORTED PROBLEM WITH EITHER MODULE OR THEIR CONNECTION TO THE NIC BOARD. AS A PRECAUTION HE REPLACED BOTH THE TEMPERATURE MODULE AND NIC BOARD ON THE RIGHT SIDE WHERE THE MODULES ARE LOCATED. ASSIGNED THE NEW TEMPERATURE MODULES IN BOTH CONFIGURATIONS AND BACKED UP CONFIGURATIONS TO CARD. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE.

    Additional Manufacturer Narrative · 1

    DURING LABORATORY ANALYSIS, THE REPORTED COMPLAINT WAS NOT DUPLICATED. NO FAILURES OR OTHER ISSUES WERE OBSERVED THROUGHOUT THE EVALUATION. NO PHYSICAL DAMAGE OR OTHER ANOMALIES OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE PERFUSIONIST (CCP) HAD INTERMITTENT ISSUES WITH THE TEMPERATURE MODULES ON THE SYSTEM-1 (APS-1). THE CCP REPORTED GETTING DASHES (---) AND INCORRECT PRESSURE READINGS ON MODULE. THE DEVICE WAS NOT CHANGED OUT, AS THEY RESEATED THE TEMPERATURE MODULE CABLES. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW ON (B)(4) 2016: THE APS-1 WAS BEING USED TO MEASURE BLADDER TEMPERATURE. A BLADDER PROBE IS A DISPOSABLE SENSOR THAT IS PART OF THE URINARY CATHETER TO HELP GUIDE CORE TEMPERATURE DURING CPB. THE PROBE IS A DISTANCE FROM APS-1 AND THIS USER (AS MANY) UTILIZES A TEMPERATURE PROBE EXTENSION CABLE. THE EXTENSION CABLE IS PLUGGED INTO (CONNECTED) TO THE APS-1 TEMPERATURE MODULE AND THE DISPOSABLE SENSOR IS CONNECTED TO THE OTHER END OF THE EXTENSION CABLE. DURING THIS CASE, (---) OR INCORRECT TEMPERATURES WERE DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM). THE USER CHANGED OUT THE EXTENSION CABLE AND TEMPERATURE ISSUES WERE SOLVED. THE TERUMO FIELD SERVICE REPRESENTATIVE (FSR) ( DAYS LATER) ALSO CHANGED OUT THE TEMPERATURE MODULE AND NETWORK INTERFACE CARD (NIC) PANEL AS A PRECAUTION. NO OTHER ISSUES HAVE BEEN SEEN. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM OBSERVED.

    Description of Event or Problem · 1

    CORRECTED INFORMATION:THE REPORTED ISSUE OCCURRED DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195055 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802114

    Patients

    Seq Age Sex Outcome Treatment
    1