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 Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported issue.The fsr found that under normal preventative maintenance (pm) testing the epgs appeared to be functioning properly, but when the epgs was connected to the oxygenator, where some resistance to flow is introduced, the epgs was not compensating for this resistance properly.This resulted in a drop in flow.The epgs was replaced.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the sweep gas flow measurements between the electronic patient gas system (epgs) and the pole mounted flow meter were off.As mitigation, the external flowmeter was used to measure the flow.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the electronic patient gas system (epgs) observed unobstructed flow was acceptable, and when obstructed, the system was able to compensate.Differences in the flow that were observed between the central control monitor (ccm) value and the flowmeter were within the expected tolerance.Per data log analysis, on 15-jan-2021 the gas system was successfully calibrated at 06:22:24.08:25:42 flow was set to 1.5 liters per minute (l/min), 09:25:16 flow was set to 1.7 l/mi,n, 09:40:24 fraction of inspired oxygen (fio2) was set to 0.83 (83%), 09:51:49 flow was set to 2.0 l/min, 09:54:13 flow was set to 2.2 l/min, 10:02:57 flow was set to 0 l/min, 10:54:25 the perfusion screen was exited.There was no indication of a problem in the log.If the flow output did not match the flow reading on the ccm, the flow meter could be faulty.The log did not confirm the complaint.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported issue.The electronic patient gas system (epgs) powered up and established good air and oxygen flow.All values when set at different setpoints were within specification.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.

• 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: 11303938
• MDR Text Key: 252004804
• Report Number: 1828100-2021-00039
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)201105
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLE MOUNTED FLOWMETER