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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) could not verify the reported issue.He checked all connections and calibrations and the unit passed all testing.The unit operated to the manufacturer's specifications.Per data log analysis, on (b)(6) 2021 a perfusion screen is opened at 06:04:24 am.Between 10:40:09, and 13:35:17, several flows were selected using the ccm slider with no indication of a problem.There were six different times flow was set to 0 liters per minute (l/min) from the ccm.The log matches what is logged when the ccm slider is pulled to 0 l/min.It was possible the user was accidently touching the ccm in two spots, one at the desired setting and one below the slider causing flow to jump to 0 l/min.There is no way to tell from the log if two touches were made.There was also a low input air pressure alarm followed by a low oxygen pressure alarm later in the log.This may have been a user checking the air and oxygen input connections.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the unit had loss of gas flow.The issue was mitigated using the manual controls for gas flow on the electronic patient gas system (epgs).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the manufacturer's clinical specialist spoke with the perfusionist regarding the loss of gas flow and central control monitor (ccm) touchscreen issue during cpb.The perfusionist indicated that at 13:38, the gas flow of the electronic patient gas system (epgs) went to zero, with no interaction with the ccm touchscreen.The perfusionist indicated that she had set up and calibrated the epgs with no issue.There were no alarms or any indication of a problem prior to, or during this event with the epgs.Upon noticing the gas flow had gone to zero, the perfusionist immediately used local controls to re-initiate gas flow.Further along the procedure, she noted that she was able to use slider controls on the ccm.There was no blood loss, harm, or delay in the procedure.After the procedure, this heart lung machine (hlm) was subsequently taken out to be serviced.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician could not duplicate the reported complaint.He powered up the electronic patient gas system (epgs) and calibrated the oxygen (o2) sensor successfully.He performed the epgs testing and did not observe any loss of gas flow or any other issues.The flowmeter was replaced as a precautionary measure.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Corrected information was received per the perfusionist observed no indication of the gas lines being disconnected and no kinks in the gas lines.The ball dropped on the flowmeter and on the central control monitor (ccm) flowmeter icon to zero liters per min (l/min).The system made a sound like it was trying to calibrate.The perfusionist added blood to the oxygenator at that time.It was also noted that a nurse reached up to connect a suction vacuum line to a vacuum device/vacuum container.It was right after the nurse plugged in this suction contained that the gas flow going to zero was observed.The field service representative (fsr) replaced the electronic patient gas system (epgs).The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) powered on the epgs connected to lab use only (luo) testing equipment for five hours with no observation of pressure loss or loss of gas flow.The epgs passed all testing and met specification.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 12451554
• MDR Text Key: 271656495
• Report Number: 1828100-2021-00322
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)171130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MECHANICAL FLOWMETER; OXYGENATOR