MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801188

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's perfusionist, the hose connections were checked and no gas leaks were heard.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) was unable to be calibrated and displayed a "service gas system-knob adjust only" message.A manual blender was used for the procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the user facility's perfusionist, she heard a clicking sound that sounded like a blender setting change from the epgs but she had not adjusted her sweep.The noise was sounding off every three seconds and after approximately 30 seconds of hearing the noise she noticed her arterial line go dark so she switched to an external gas tank.The numbers on the monitor did not match the dial settings even though the light underneath the pump was green.She tried to recalibrate the gas after switching to the gas tank but it failed.

Event Description

Per clinical review: on (b)(6) 2018, the electronic patient gas system (epgs) was set up and calibrated without issue for a cardiopulmonary bypass (cpb) procedure.During cpb, the perfusionist heard a clicking sound that she stated "sounded like the clicking sound that usually accompanies a blender setting change", but they had not changed the sweep gas setting.The fraction of inspired oxygen (fio2) setting was around 58% and the sweep gas setting was around 1.8 l/min, prior to the incident occurring.The perfusionist then noticed that it was actually reading for the sweep gas flow and the fio2 were not what the end-user had set it at - approximately 58% and 1.8 liters per minute (l/min).After about 30 seconds of the clicking noise, it was noticed that the arterial blood was turning dark, therefore the perfusionist decided to go to an external oxygen tank.Next, the end-user asked a colleague to retrieve an external blender, and used that device to control gases to the patient's oxygenator.The exchanging of the gas source was very quick and the patients partial pressure of carbon dioxide (pco2) and partial pressure of oxygen (po2) values were not affected.The end-user did not recall any audible or visual notifications on the central control monitor (ccm) messaging area when this occurred.The end-user stated there were no leaks in the set-up of their gas system during this period.The system is set up as suggested in the heart lung machine (hlm) instruction for use (ifu), with the epgs outlet being connected to the vaporizer, then an external flow meter and then to the oxygenator.Once the patient was stable on an external blender, the perfusion team opted to try to recalibrate the epgs, but the system gave the team a "service gas system" error message and the system was unable to be calibrated.There was no delay of the surgical procedure due to this incident.There was no harm or blood loss associated with the event.

Manufacturer Narrative

Per data log analysis: date problem occurred (b)(6) 2018 ,not the 4th 11:25:39 calibration started.11:27:25 calibration successful o2 sensor reading 1571mv.11:28:13 am ccm flow change to 1.8l/min.11:28:13 am ccm fio2 change to 65%.14:09:29 ccm fio2 change to 62%.14:23:49 fio2 change to 60%.14:25:04 ccm flow change to 2l/min.14:25:48 ccm fio2 change to 100%.14:26:29 o2 sensor and blender disagree fio2 set point @100% o2 reading 57%.14:28:39 ccm fio2 change to 99.9%.14:35:06 ccm flow change 0 l/min.14:35:06 ccm fio2 change to 21%.14:35:41 calibration started.14:35:42 calibration failed zero flow high before cal 6.81l/min.Prior to starting calibration ,the electronic patient gas system (epgs) software turns the flow valve fully counter clockwise (ccw), the software then takes a reading from the flow meter, the value should be zero liters/min (l/min).The value showing in the log is 6.81 l/min so the software attempts to turn the flow valve ccw, this is the chatting that was noticed during the second calibration.There were two more calibrations initiated and the same failure was observed ¿calibration failed zero flow high before cal 6.81l/min¿.The likely cause to this issue is the flow meter.During laboratory analysis, the product surveillance technician (pst) observed the calibration failure, "service gas system - knob adjust only" message, and chatting noise caused by a defective internal flowmeter.He connected the epgs to an advanced perfusion system one (aps1) simulator and central control monitor (ccm), attached oxygen (o2) and air at 50 pounds per square inch (psi), entered perfusion screen on the ccm and waited the 15 minute o2 sensor warm-up period.After the warmup period, calibration of the epgs was initiated and failed.During calibration, the air flow increased past 5.0 l/min to its maximum flow rate measured with an external flow meter.Calibration flow rate is 5.0 l/min.The flow knob started clicking after it reached its full rotation and kept trying to rotate.Next, a ¿service gas system-knob adjust only¿ message was displayed on the ccm.Measured the output voltage of the internal flowmeter and it did not vary from five volts at any flow rate.Normally, the output voltage is five volts at zero flow and the voltage decreases as flow increases.The internal flowmeter was replaced with a lab use flowmeter.After a 15 minute warmup period, calibration of the epgs was initiated and passed.Per the supplier evaluation, the unit was received with a large tare value (43732).When removed, the device was reading 12.8 standard liters per minute (slpm) at zero flow.Adc differential pressure reading maxed out (65370 versus 9889 at time of manufacture).Sensor bridge also shifted from 38807 counts to 25332, rendering absolute pressure inaccurate (27.18 pounds per square inch (psi) at atmospheric of 13.61 psi).Attempted resoldering sensor with no results.234 millivolt (mv) offset found on differential pressure sensor, well out of bounds of normal values and accounting for shift in differential pressure readings.Suspect more than one loose wire bond on differential pressure sensor.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.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8176321
• MDR Text Key: 131502861
• Report Number: 1828100-2018-00647
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)100428
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 01/02/2019; 02/05/2019
• Supplement Dates FDA Received: 12/21/2018; 01/22/2019; 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DWYER GAS FLOW METER.; EXTERNAL GAS BLENDER.; EXTERNAL GAS TANK.; OXYGENATOR.; TEC 7 VAPORIZER.
• Patient Outcome(s): Required Intervention