BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4844530 · Received June 11, 2015

    Report

    Report Number
    1828100-2015-00491
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 20, 2015
    Report Date
    August 28, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING LABORATORY EVALUATION, THE COMPLAINT WAS NOT DUPLICATED. NO ABNORMAL ALARMS OCCURED DURING TESTING OF THE AIR SENSOR AND MODULE. THE PRODUCT SURVEILLANCE TECHNICIAN (PST) PHYSICALLY AGITATED THE AIR SENSOR AND ITS CONNECTOR DURING TESTING WHICH DID NOT CAUSE FAILURE. THE PST VISUALLY EXAMINED THE AIR SENSOR WITH NOTHING OBSERVED THAT WOULD CAUSE FAILURE. THE PST TESTED THE MODULE AND SENSOR OVER A FIVE DAY PERIOD WITH NO ABNORMAL ALARMS OCCURING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED. DATA LOG ANALYSIS WAS PERFORMED ON THE AIR BUBBLE DETECTOR (ABD) MODULE LOGS. LOGS SHOWED MULTIPLE INSTANCES OF THE 8 VOLT (V) POWER SUPPLY TO THE ULTRASONIC AIR SENSOR FALLING OUTSIDE THE 8.0 +/- 0.4 VOLTS DIRECT CURRENT (VDC) DESIGN SPECIFICATION. LOW VOLTAGES WERE OBSERVED ON THIS LINE. DURING LABORATORY ANALYSIS, THE MODULE¿S POWER SUPPLY TO THE SENSOR WAS MEASURED TO BE 7.97 VDC WHICH IS WITHIN THE 8.0 +/- 0.4 VDC DESIGN SPECIFICATION. THE UNIT WAS RETURNED TO THE LAB FOR FURTHER TESTING. THE 8V SENSOR SUPPLY LINE WAS MONITORED WITH AN OSCILLOSCOPE SET TO TRIGGER IF THE VOLTAGE DROPPED BELOW THE 7.6 VDC DESIGN SPECIFICATION. DURING 48 HOURS OF MONITORING, THERE WERE NO ISSUES FOUND WITH THE SUPPLY VOLTAGE. SYSTEM WAS PLACED IN COLD SOAK FOR THREE HOURS THEN MONITORED. AFTER 96 HOURS OF ADDITIONAL TESTING, INCLUDING THE SYSTEM WARMING BACK UP TO AMBIENT TEMPERATURE, THE SYSTEM EXHIBITED NO VOLTAGE ANOMALIES. FROM CORRESPONDENCE WITH CUSTOMER, THE MANUFACTURING ENGINEERING CENTER (MEC) FOUND THE DEVICE WAS USED PER THE OPERATORS MANUAL, WITH THE EXCEPTION THAT IT WAS NOT TESTED BEFORE THE CASE. A LETTER WAS SENT TO MEC INSTRUCTING THEM TO REINFORCE TO THE CUSTOMER TO FOLLOW THE OPERATORS MANUAL, INCLUDING THE "TEST BEFORE USE" SECTION. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR#: 1828100-2015-00492 AND 1828100-2015-00493. THE PERFUSION SYSTEM WAS SET-UP FOR AN URGENT DISSOCIATION SYMPTOM. THE SALES REP AND SERVICE ENGINEER CHECKED THE AIR SENSOR, BUT THE REPORTED ISSUE WAS NOT DUPLICATED. THEY CHECKED AIR SENSOR EVENT LOG. ON THE LOG, EVENT LOG "8VDC POWER SUPPLY ERROR" WAS RECORDED ON THE ISSUE'S OCCURRENCE TIME AND DATE. IT WAS THEIR FIRST TIME SEEING THIS ERROR MESSAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, AFTER CARDIOPLEGIA (CPG) SOLUTION PRIMING, THE AIR BUBBLE DETECTOR (ABD) ALARMED BY ENABLING THE ABD SENSOR ON THE CENTRAL CONTROL MONITOR (CCM). THE ISSUE WAS NOT SOLVED EVEN AFTER RECONNECTING THE MODULE AND CABLE, AND THE ABD AND CABLE. THE CUSTOMER STOPPED USING THE ABD. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380898 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802110

    Patients

    Seq Age Sex Outcome Treatment
    1