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 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) could not verify the issue.He opened the epgs and inspected for loose connections or damaged parts and found nothing.The epgs passed verification and release testing.The fsr ran the gas flow and o2 at the same setting the perfusionist had during the time of the issue reported with no sudden changes.The fsr contacted the manufacturer¿s technical support specialist directly to review the logs.No parts were replaced.The unit operated to the manufacturer's specifications.Per data log analysis, on 17-apr-2020 the gas system is successfully calibrated at 6:45:20 am.Flow settings and flow output were captured during the case.There is no indication of a problem with the gas system in the log.The only notable event is flow was set low (0.37 l/min) from 07:02:07 am to 09:08:57 am.The issue was reported to have occurred at 9:00 am.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit had a sudden loss in oxygen (o2) and a rise in patient carbon dioxide (co2).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2020, the team set up for the cpb procedure and calibrated the electronic patient gas system (epgs) without issue for the case.The fraction of inspired oxygen (fio2) and the sweep gas were set by the perfusionist when going on bypass.The case ran normally until approximately an hour into the pump run.There was no change in the slider set location of the sweep gas, and the measured flow did not change either, but the perfusionist did recall hearing an audible sound from the epgs as if it was changing automatically.He then noticed a decrease in the partial pressure of oxygen (po2) of the patient and an increase in the partial pressure of carbon dioxide (pco2) of the patient as measured with the blood parameter monitor (bpm).He did not recall any error messages on the heart lung machine (hlm), additionally, he spoke with his biomedical technician, to ensure that there was no loss of gas pressure during the procedure.The forane vaporizer was working appropriately.He recalled that the independent mechanical flow meter was reading what he originally set it to at 2.5 liter per minute (l/min).Once he saw the changes in the pco2 and po2, he increased his sweep gas to the oxygenator, and the issue did resolve itself, and the values stayed consistent throughout the remainder of the procedure.This incident did not delay the continuation of the surgical procedure.There was no harm or blood loss associated with the event.

Manufacturer Narrative

The reported complaint could not be confirmed.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: 10048541
• MDR Text Key: 201434024
• Report Number: 1828100-2020-00192
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)190823
• 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
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FORANE VAPORIZER; MECHANICAL FLOWMETER; OXYGENATOR