MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2023

Event Type  malfunction  

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.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they have a difficulty in cannulation.There was a delay in the procedure, however it is unknown if how many minutes, the product was changed out, there was no blood loss, and the surgery was completed successfully.As per the perfusionist, the hls cannula on the arterial femoralis right was at 21 and the venous cannulation was difficult.Initially, for almost 30 minutes, the venous backflow was only possible via suction.Cannulation via the superior and inferior vena cava.To obtain better venous return, the venous vacuum therapy (sevaco) was applied.Continue sucking a lot of blood via three suction units.Blood flow at the beginning was about 70% (=3.7 l/min), later with sufficient backflow 100% (=5-5.3 l/min).Act was always in the normal range (=>500 s) except for the last 344s; therefore, the administration of 5000 iu of heparin.Bypass time: 249 min; aortic clamp time: 97min, and reperfusion time: 80 min.After about 2 hours of bypass time, it was noticed that the blood bag was inflated.Thus, it had to be an overpressure on the side of the cardiotomy reservoir.The pressure was so high that the blue end cap was catapulted 3/8 inch off the reservoir.After increasing the suction several times from -25 mmhg to finally -80 mmhg, with no improvement.The sevaco tube was removed, and did not lead to an improvement.In her opinion, the filter in the cardiotomy reservoir was completely blocked and therefore impermeable to the patient's blood.Filling the reservoir via the inlet port was only possible with great pressure.She then decided to swap the inlet tube to the front vent port of the venous reservoir and to open the luer lock plug on the opposite side.The surgical side reported that no coagulum was visible in the site.She have considered replacing the reservoir including the oxygenator.However, the ecc could be ended prior.After the end of the ecc, the reservoir was emptied and a large amount (500-1000 ml) of non-coagulated blood came out of the cardiotomy reservoir.Fibrin threads were found in the cell saver drainage bag, which closed the drainage valve.Additionally, loss blood was reinfused to the patient.Additionally, as per the subsidiary, the surgery was for a re-ake and mke in endocarditis.

Event Description

Additional information from the clinical specialist states that, the complaint from luxembourg involved the reservoir of a fx25 oxygenator that had drainage and positive pressurization issues during cardiopulmonary bypass.The reservoir/oxygenator was not changed out during the bypass run and the surgery was successfully completed.The bypass time was a total of 249 minutes.The patient was 186cm tall and with a bsa of 2.2m2.The surgeon had difficulty cannulating both the arterial and venous sides.The venous cannulation was very difficult, resulting in assisted vacuum drainage being used to improve venous drainage.Initially, the target arterial blood flows were not optimal for this patient as a result of the poor venous drainage and thus low reservoir blood volume.Three sucker units were used to facilitate improve venous reservoir levels.Per the clinician, at about 2 hours of bypass time, the initially empty blood bag on the prime line to the reservoir became inflated, indicating pressurization of the cardiotomy reservoir.A cap on the reservoir popped off.Vacuum was increased in attempt to improve reservoir pressure and venous drainage.The perfusionist decided not to change the reservoir out as the case was close to being completed.At the end of the case, 500-1000ml of non-coagulated blood was drained from the cardiotomy reservoir.The bypass run began at approximately 12pm and ended at 4pm.The patient received a loading dose of 30,000 iu of heparin to begin bypass.The post heparin act value was greater than 999 seconds.The subsequent acts were acceptable (above 480 seconds) until a little after 3pm, at that point an act value of 344 seconds was realized.This is significantly below acceptable levels and a point when significant clotting of the cardiotomy reservoir would probably occur.It was approximately half an hour between the last acceptable act value of 513 seconds at approximately 245p and the unacceptable value of 344 seconds at approximately 315p during which active rewarming of the patient was occurring.The perfusionist gave an additional 5000iu of heparin at this point, which is not a sufficient amount considering the size if the patient (2.2m2) and low act value of 344 seconds.The probability of clotting of the cardiotomy reservoir greatly increased with lower heparin levels and a sub-optimum venous blood flow return.

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 march 29, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem).D3 (email address).D4 (additional device information - added exp date).G1 (corrected contact office- title, name, email address).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 10, 3331, 213, 67).Type of investigation#1: 10- testing of actual/ suspected device.Type of investigation#2: 3331- analysis of production records.Investigation findings: 213- no device problem found.Investigation conclusions: 67- no problem detected.The affected sample was inspected upon receipt and it was noted to have mold growing on the outside of the cr filter.The sample was tested for clotting with bovine blood at 5 l/minute for 1.5 hours with no clotting on the filter observed in the cardiotomy portion of the reservoir.After clot testing, no clotting was observed in the cardiotomy portion of the reservoir.It is likely that patient conditions or inadequate heparinization of the patient contributed to the formations of clots within the reservoir filter.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25REC 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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16639612
• MDR Text Key: 312301613
• Report Number: 1124841-2023-00077
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 2H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 96 KG