BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7216757 · Received January 24, 2018

    Report

    Report Number
    1828100-2018-00037
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    January 2, 2018
    Report Date
    October 3, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K163531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURER¿S SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. 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 · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURER¿S SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. 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 · 0

    PER DATA LOG ANALYSIS, ON (B)(6) 2018: 06:57:08 SYSTEM IS POWERED ON. 06:57:11 SYSTEM PUMP DIRECTION IS SET TO CCW. 07:00:07 PERFUSION SCREEN IS OPENED. 07:00:13 SYSTEM PUMP DIRECTION IS SET TO CCW. 07:46:20 PERFUSION SCREEN IS EXITED. 07:46:36 CCM IS SHUT DOWN. 07:48:17 SYSTEM IS POWERED ON. 07:48:21 SYSTEM PUMP DIRECTION IS SET TO CCW. 07:50:51 PERFUSION SCREEN IS OPENED. 07:50:57 SYSTEM PUMP DIRECTION IS SET TO CCW. 10:17:01 USER SET PUMP DIRECTION TO CW. 10:18:04 PUMP WAS STARTED AND STOPPED (DIRECTION WILL REVERT TO CCW). 10:18:42 USER SET PUMP DIRECTION TO CW. SEVERAL START/STOPS OCCUR WITCH WILL REVERT THE PUMP TO CCW. 11:33:51 PERFUSION SCREEN IS EXITED. 11:37:16 CCM IS SHUT DOWN. THERE IS NO INDICATION IN THE LOG OF THE SCREEN GOING BLANK. IT IS POSSIBLE FOR THE DISPLAY TO GO BLANK WITHOUT LOGGING ANYTHING. IT IS POSSIBLE THE SCREEN WENT BLANK WHILE THE PUMP WAS SET FOR CW. IF THE USER STOPPED THE PUMP, THE PUMP DIRECTION WOULD REVERT BACK TO THE SYSTEM DIRECTION WHICH IS NORMAL BEHAVIOR.

    Additional Manufacturer Narrative · 0

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 0

    PER CLINICAL REVIEW: TOWARDS THE END OF THE CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2018 THE ROLLER PUMP ON THE HEART LUNG MACHINE (HLM), WHICH WAS SET UP IN A MASTER/FOLLOWER CONFIGURATION, AND BEING USED IN THE FOLLOWER POSITION MADE A LOUD NOISE AND SHUT OFF. THE SCREEN ON THE LOCAL DISPLAY WAS BLANK AND PUMP WAS OFF. THE PUMP AUTOMATICALLY CAME BACK ON, BUT THE FLOW INDICATION WAS IN REVERSE FLOW. ONCE THEY PRESSED THE ON/OFF BUTTON TO ENGAGE THE FOLLOWER PUMP, THE REVERSE FLOW INDICATOR DID CHANGE TO THE CORRECT DIRECTION. THE OCCURRENCE WAS TOWARD THE END OF THE PROCEDURE, THEREFORE ONLY COLD BLOOD WAS NEEDED FOR MYOCARDIAL PROTECTION AND THE TEAM ONLY NEEDED TO USE THE MASTER PUMP FOR DELIVERY OF COLD BLOOD TO THE MYOCARDIUM. THE TEAM DID STATE THAT BECAUSE OF THE UNUSUAL SEQUENCE OF EVENTS THAT THEY WERE CONCERNED ABOUT THE USAGE OF THAT PARTICULAR ROLLER PUMP, BUT THAT IT WAS NOT NEEDED TO FINISH THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE USER FACILITY, THE ROLLER PUMP WAS BEING USED IN THE CARDIOPLEGIA (CPG) POSITION. DURING THE PROCEDURE THE ROLLER PUMP WAS MAKING A LOUD NOISE WHEN THE CPG WAS NOT RUNNING. THE DISPLAY WENT BLANK AND WHEN IT CAME BACK ON IT WAS SHOWING THE FLOW IN REVERSE. THERE WAS A SECOND OCCURRENCE RIGHT AFTER THE FIRST OCCURRENCE. THE PROCEDURE WAS FINISHED WITHOUT USING ANY CPG.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS UNABLE TO DUPLICATE THE COMPLAINT. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THE DISPLAY ON THE ROLLER PUMP TO FUNCTION AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE DISPLAY WENT BLANK. 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
    58057 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801040

    Patients

    Seq Age Sex Outcome Treatment
    1