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 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Per data log analysis, on (b)(6) 2019, there is no indication of a problem in the gas system log.There is one instance where fio2 was changed from 60.9% to 24.7%.This change was from a local knob turn.The field service representative (fsr) completed testing without finding any issues.He discussed the log analysis with the perfusionist.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the fraction of inspired oxygen (fio2) of the unit changed down to 21% on its own.The fio2 was adjusted back to the desired setting.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 issue was discovered on november 18, 2019 during a cardiopulmonary bypass procedure (cpb) on (b)(6) 2019.The team set up and calibrated the unit without issue for the case.During the case, the team stated that the fraction of inspired oxygen (fio2) had changed down to 21% on its own, but per the log data obtained from the unit, the change was from a manual knob adjust from 60.9% fio2 to 24.7% fio2.The fio2 once noticed that it was at a low level was then increased to the appropriate level, and the case proceeded without any additional issues regarding the fio2 output.The unit was not exchanged during the procedure, and the electronic patient gas system (epgs) worked as expected the remainder of the case.There was no delay in the surgical procedure.There was no harm or blood loss related to the incident.

Manufacturer Narrative

The reported complaint was 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: 9451538
• MDR Text Key: 199112635
• Report Number: 1828100-2019-00654
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)090211
• 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
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1