MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator stop oxygenation suddenly.Per facility, the device was retaining c02 at first but oxygenating well with a sweep of 2lpm.After increasing the sweep twice, without improvement, the oxygenator stopped oxygenating all of a sudden.The decrease in oxygenation occurred around 30 minutes on bypass and 15 minutes to change the oxygenator.The exact amount of decrease in oxygen is unknown.The intended surgery was not completed.The patient was weaned off bypass and was not able have the mitral valve replacement surgery.The patient had a successful mitral valve replacement surgery last (b)(6) 2022 and was doing fine.The surgeon required the perfusionist to use a competitive oxygenator, a livanova oxygenator.No blood transfusion required due to blood loss.There was 15 minutes of delay in the procedure.There was 500 ml of blood loss occurred during changed out.The product was changed out.The surgery was not completed successfully.

Event Description

New information received states that patient is 74 y/o female, 170cm, 60 kg, bsa 1.7, smoker.Explained patient retains co2.Post-mitral ring and needed reoperation for mitral replacement and cabg.Patient hct 30.First on bypass was 21.System 1 pump primed just prior to (b)(6), on monday, (b)(6)2022.Albumin is used in prime.Cdi550 utilized; gem blood gas used.Hms used for act.Cerebral saturations were closely monitored.20k heparin used pre bypass, additional 5000 given to achieve acceptable act for bypass.Act 499 with hepcon 2.0.On bypass, line pressures normal with mean 200, flow 3.4 l/min.Blood pressure mean 88.Patient temp drifted at 0917.Prior to oxygenator failure, target flows were maintained with a cardiac index of 2.4 and lowest blood flow seen at 3.4 l/min.Rpm were 2190 at 4.2 l/min and blood pressure 64 mmhg.Failure discovered 30 min after bypass initiation.Surgeon notified at 1002.All equipment checked prior to change-out.Flow meter matched sweep during incident, pre and post oxy gases monitored, 100% o2 used with no increased oxygenation.Eliminated vaporizer to see impact but this did not increase oxygenation.Surgeon removed x-clamp and weaned from bypass.Anesthesia began ventilation.Oxygenator was changed out in-tandem via y-connector in a-line (ie a large-shunt).They did not have any connectors to do a full change out, so oxy was added in a series fashion.Blender changed as well as two separate 100% o2 tanks used for each oxy (new & old).Anesthesia does not use propofol on bypass.Additionally, the pump record was reviewed, stating that, the bsa was 1.69 m2, and the target blood flow rate during extracorporeal circulation was assumed to be approximately 4.1 l/min.When checking the blood flow rate, it was found that the flow rate exceeded 4 l/min only at 9:20, and that it was in the 3 l/min range at other times.When checking the gas flow rate, the gas flow rate at 9:20 at the start of circulation was 2.0 l/min, and fio2 was 80%.Not started with v/q=1.At 9:25, pco2 showed 70mmhg, but the gas flow rate was 2.0l/min.At 9:45, pco2 became 81mmhg, and at 9:55, raised the gas flow rate to 4.5l/min.However, lowered fio2 to 70%.At 9:45, 2000 ml of cp was shot.Hb was 8.8 at 9:45 and dropped to 7.0 at 10:02.Be was not stable between -3.5 and -10.6 and showed a low value of -10.6 at 10:02.Ultrafiltration and blood transfusion were performed at 10:10 to address hemoconcentration.This treatment was performed after 10:02 (the time when the event occurred, and the surgeon was notified) as described in the report.Although nahco3 was administered at 10:22, this treatment was performed after 10:02.Even at 10:49, be was a low value of -5.9.At 10:16, pco2 was 62mmhg and po2 was 396mmhg.At 10:18, new oxygenator added.There were signs of improvement before on pomp at 10:20.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 25, 2022.Upon further investigation of the reported event, the following information is new and/or changed: a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b5 (additional describe event or problem) b6 (relevant tests/laboratory data - added blood type) b7 (added other relevant history) d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 4643, 10, 3331, 213, 67) health effect - impact code: 4643 - blood transfusion type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation finding: 213 - no device problem found investigation conclusions: 67 - no problem detected the actual sample was visually inspected and found no anomaly such as breakage that could lead to gas transfer failure.After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure.It was confirmed to meet the factory's specifications.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specification, and no anomaly was found in the manufacturing records.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information as per clinical specialist that, an oxygen tank was used to replace wall gas source to try and troubleshoot the issue with no change in oxygenation and increasing gas sweep rates did not improve co2 removal.With no improvement in gas exchange and decreasing saturations, the perfusionist decided to add a fx15 oxygenator in tandem with the fx25 oxygenator.The surgeon was informed, and the patient was placed back on the ventilator and bypass was stopped.The fx15 was added into the circuit with the fx25 oxygenator.This took approximately 15 minutes during which the patient was supported safely by anesthesia.Both oxygenators were connected to oxygen tanks and bypass was re-initiated to complete the cabg surgery.The addition of the fx15 oxygenator drastically improved the oxygenation and co2 removal upon the return of the patient to bypass.There was 800cc of cellsaver of patient's blood returned.There was 2 units, 600cc of banked blood given to patient.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15666139
• MDR Text Key: 302335060
• Report Number: 1124841-2022-00168
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2K22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG