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 Gas Output Problem (1266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Per the manufacturer's subsidiary, when the flow rate was set to zero on the central control monitor (ccm) there was still approximately a two liters per minute (l/min) flow.The flow rate of blood was 0.75 l/min, fraction of inspired oxygen (fio2) 55% and the gas flow about 0.1-0.2.The carbon dioxide (co2) was unstable so the user added co2.About 40 minutes after turning the pump on, the user saw that the analog flow indicator was reading approximately two l/min.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) had a gas flow failure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the electronic patient gas system (epgs) calibrated without issue for a cardiopulmonary bypass (cpb) procedure on (b)(6) 2019 shortly after going on bypass, the team noticed that the gas flow on the central control monitor (ccm) was reading zero and the analog one in line was reading about two liters per minute (l/min).Fraction of inspired oxygen (fio2) at this time was 55%.The team during calibration and during the procedure did not recall any gas messages or failure messages.The team was also able to notice that the partial pressure of carbon dioxide (pco2) level was different than expected for the set flow rate, but they did not recall what their actual set point was for the gas sweep rate.The decision was made to continue the procedure without changing to an external gas blender or tank, they just adjusted the values off of the information available on the analog external flow meter.There was no delay in the continuation of the surgical procedure.There was no reported harm or blood loss due to this issue.

Manufacturer Narrative

Updated blocks: h3, h6 and h9.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) duplicated the complaint.The electronic patient gas system (epgs) failed calibration due to the flowmeter.Replacement of user facility¿s flowmeter with lab use only (luo) flowmeter enabled the epgs to calibrate and function as indented.Per data log analysis, the gas system is successfully calibrated at 09:09:45 on 06-jun-2019.09:10:40 flow is set to 0.03 l/min using the knob.11:36:37 flow is set to 0.39 l/min using the ccm.11:39:19 flow is set to 0.19 l/min using the ccm.11:46:16 flow is set to 0.09 l/min using the ccm.12:17:56 flow is set to 1.09 l/min using the ccm.12:41:55 flow is set to 0.89 l/min using the ccm.13:41:17 flow is set to 0.49 l/min using the ccm.13:49:25 flow is set to 0.00 l/min using the ccm.13:51:01 flow is set to 0.02 l/min using the knob.13:53:22 flow is set to 0.12 l/min using the ccm.14:27:05 flow is set to 0.00 l/min using the ccm.The gas system did not have any errors.The flow meter may have been measuring flow lower than actual flow.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: 8748763
• MDR Text Key: 149657726
• Report Number: 1828100-2019-00348
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• 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: 06/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-04/12/19-002-C
• Patient Sequence Number: 1
• Treatment: EXTERNAL FLOW METER; EXTERNAL FLOW METER