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 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Per data log analysis, on 08-jan-2021 the end user reported a 'gas blender failure' occurred.The system was left powered on 7-jan-2021 and was shut down on 8-jan-2021 at 04:27:41 am.The system is powered up again at 02:01:23 pm on 08-jan-2021.14:12:36 a perfusion screen is opened.14:38:05 calibration is successfully performed.14:41:28 flow is set to 0 liters per min (l/min).16:35:45 flow is set to 2.05 l/min.16:38:31 fio2 is set to 0.818 (81.8%).16:39:54 fio2 is set to 0.75 (75%).16:42:21 fio2 is set to 0.80 (80%).16:52:39 flow is set to 2.25 l/min.16:54:40 flow is set to 3.05 l/min.16:58:00 flow is set to 3.57 l/min.18:07:23 fio2 is set to 0.89 (89%).18:07:38 fio2 is set to 0.90 (90%).18:19:54 fio2 is set to 0.996 (99.6%).18:45:03 flow is set to 3.11 l/min.19:13:04 flow is set to 0 l/min.21:40:27 the perfusion screen is exited.There is no indication of an issue in the log.The field service representative (fsr) verified the issue.The epgs was found to be out of specification on high flow settings.As a result, the epgs was replaced.The unit operated to the manufacturer's specifications.The suspect unit will be returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the gas blender failed.As a result, the perfusionist switched to a portable oxygen (o2) gas tank.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 an incident the team had with the electronic patient gas system (epgs) on the heart lung machine (hlm) during a cpb procedure on (b)(6) 2021.The epgs calibrated without issue for a case.During the procedure the perfusionist stated that the patient's partial pressure of oxygen (po2s) on bypass drastically and quickly dropped from high 300 millimeter of mercury (mmhg) to low 200 mmhg.He checked the connections to the oxygenator, to the epgs, from the lines to the boom and made sure all connections were complete and tight.The perfusionist stated that he felt the connects to the boom and all were tight and he heard no noise that would indicate that there was a gas pressure leak.The team had the connections checked and confirmed with biomed and there was no leak in the hospital system.The team has had a few epgs incidents in the past, therefore the manufacturer's clinical specialist spent some time discussing all mitigations and possible scenarios with the team.Patient variability on warming was discussed, as well as depth of anesthesia and both were appropriate at this time per the clinician.The team did switch o2 source to stand-alone o2 tank and the patient's po2 values increased.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss due to this occurrence.

Manufacturer Narrative

During testing of the device at the service center, the service repair technician (srt) was not able to duplicate the reported issue.The electronic patient gas system (epgs) was powered up and good air and oxygen flow were established.The oxygen sensor calibrated successfully.There was no gas blender failures observed.The unit was reconditioned.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the electronic patient gas system (epgs) to function as intended.The epgs was connected to a lab use only (luo) heart lung machine (hlm) and central control monitor (ccm).The oxygen (o2) percent hours where within acceptable range.The epgs passed the o2 sensor calibration.Each gas flow rate setpoint was checked and manually adjusted throughout the system's functional range with no fault observed.The fraction of inspired oxygen (fio2) blend function was checked and passed using an external o2 analyzer to verify.The fio2 blend could be set manually throughout the system's functional range with no issues observed.Independently obtained measurements were within expected tolerances.

Manufacturer Narrative

The reported complaint was confirmed by the field service representative but was unable to be duplicated in the lab or during service testing.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: 11269682
• MDR Text Key: 252001289
• Report Number: 1828100-2021-00029
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)110317
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• 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: 02/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGENATOR
• Patient Outcome(s): Required Intervention