BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 8764020 · Received July 5, 2019

    Report

    Report Number
    1828100-2019-00361
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 11, 2019
    Report Date
    September 12, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BLOCK: H6. THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY EVALUATION, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THE DISPLAY TO PUMP BOARD CABLE TO FUNCTION AS INTENDED THROUGHOUT THE EVALUATION. 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

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. ALONG WITH THIS PUMP THERE WERE ALSO TWO OTHER PUMPS AND A FEW MODULES CONNECTED TO THE LEFT SIDE NETWORK INTERFACE CONTROLLER (NIC) POD. HE CHECKED THE EXTERNAL AND INTERNAL PUMP CABLES AND THEY WERE ALL SEATED PROPERLY WITH NO VISUAL DAMAGE. HE CHECKED THE PUMP LOG HISTORY AND DID NOT SEE AN ERROR OCCUR AT THE TIME OF THE COMPLAINT. HE REPLACED THE DISPLAY TO PUMP CABLE. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE SUSPECT PART WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION PER DATA LOG ANALYSIS ON (B)(6) 2019: 06:06:23 PERFUSION SCREEN OPENED; 06:08:48 ARTERIAL LARGE ROLLER PUMP IS STARTED; 06:38:06 AIR DETECTED ALARM OCCURS STOPPING THE ARTERIAL PUMP; 06:39:09 PUMP IS STARTED; 07:23:05 ARTERIAL SPEED SET TO 0 L/MIN; 08:01:26 ARTERIAL IS STOPPED USING LOCAL CONTROLS; 08:25:19 PUMP IS STARTED; 12:23:09 ARTERIAL IS STOPPED USING LOCAL CONTROLS; 12:23:32 DIRECTION IS SET TO CLOCKWISE; 12:23:37 PUMP IS STARTED; 12:26:37 PUMP IS STOPPED; 12:29:00 DIRECTION IS SET TO CLOCKWISE; 12:29:02 PUMP IS STARTED; LID OPENED AND CLOSED 3 TIMES; 12:33:49 PUMP IS STOPPED; 12:52:31 PERFUSION SCREEN IS EXITED; NO WAY TO TELL FROM THE LOG WHICH, IF ANY, ARE THE REPORTED PUMP STOP. ON (B)(6) 2019: 06:07:55 ARTERIAL LARGE ROLLER PUMP IS STARTED; 06:09:23 PERFUSION SCREEN OPENED; 13:07:18 PUMP SPEED SET TO 4.373 L/MIN; 13:21:53 PUMP STOPPED AND STARTED USING THE CCM; 14:05:23 ARTERIAL SPEED SET TO 0 L/MIN; 14:07:55 ARTERIAL STOPPED USING LOCAL CONTROLS; 14:09:14 DIRECTION IS SET TO CLOCKWISE; 14:09:21 ARTERIAL IS STARTED USING LOCAL CONTROLS; LID IS OPENED AND CLOSED 6 TIMES; 14:43:38 PERFUSION SCREEN IS EXITED STOPPING THE ARTERIAL PUMP. NO WAY TO TELL FROM THE LOG WHICH, IF ANY, IS THE REPORTED PUMP STOP. THERE IS NO INDICATION IN THE LOG WHAT STOPPED THE PUMP UNEXPECTEDLY AS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ARTERIAL PUMP HEAD SPEED WENT TO ZERO IN THE MIDDLE OF THE CASE WITH NO ALARMS. THEY TURNED TO THE FLOW BACK UP. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: ACCORDING TO THE INFORMATION AVAILABLE, THERE IS NO LOG DATA FOR THE REPORTED DATE OF WHEN THE INCIDENT OCCURRED ON (B)(6) 2019, LOG DATA AVAILABLE FOR (B)(6) 2019, WITH NO INDICATION IN THE LOG DATA ON WHAT MAY HAVE OCCURRED TO HAVE THE ARTERIAL ROLLER PUMP GO TO ZERO (STOP). DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2019. THE ROLLER PUMP WAS SET UP AND THE SYSTEM WAS PRIMED WITHOUT ISSUE. WHILE THE PATIENT WAS ON BYPASS, THE ARTERIAL ROLLER PUMP WENT TO 0.00 AND STOPPED. THE ROLLER PUMP DID NOT TURN OFF. THE PERFUSIONIST STATED THAT THE BUBBLE DETECTORS THEY HAVE ON THEIR SYSTEM DID NOT ALARM AND RESPOND, AND THERE WERE NO CORRESPONDING ALARMS OR NOTIFICATIONS OF A PROBLEM. THEY DID SEE THE ARTERIAL ROLLER PUMP READING 0.00 LITERS PER MINUTE (L/MIN), AND HE WAS ABLE TO COME UP ON FLOW WITHOUT ANY ISSUE. (THE TEAM USES A 1/2 BOOT IN THE ARTERIAL ROLLER PUMP). THIS ONLY OCCURRED ONCE DURING THE PROCEDURE. THE TEAM DID NOT EXCHANGE THE ROLLER PUMP, FOR THE CASE CONTINUED WITHOUT ANOTHER ARTERIAL ROLLER PUMP STOPPAGE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557372 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801041

    Patients

    Seq Age Sex Outcome Treatment
    1