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

Model Number 3CX*FX25REC

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenation was low.After the 100% bypass, a cooling down to approximately 30 degrees celsius was performed.Bga (blood gas analyzer) controls were carried out at regular intervals during the cooling phase.The bga (ph stat during cooling) were always, as usual, within the normal range.There was no evidence of oxygenator malfunction during antegrade cerebral perfusion either.After the antegrade cerebral perfusion was finished and the patient was warmed up again, they went to 100% fio2 and increased the fresh gas flow to 7.5 l/m for 2-3 min., because the oxygen is greatly increased during this phase.At the same time, they put 2 x 50ml sodium bicarbonate in the heart-lung machine.During another bga (blood gas analyzer), they found that the po2 content was too low.Then they took the fio2 to 100% and at the same time carried out a flash with 10l/m for about one second.Afterwards they did another bga.The values have slightly improved.In the meantime, the aorta has been opened and the patient re-perfused.Weaning from the cardiopulmonary bypass was initiated by the surgery, anesthesia, and cardio technical departments.The patient could not be weaned off the heart-lung machine at this stage of the surgery.A change during this phase of the surgery was not indicated.After it was established that the patient still needed a longer phase of reperfusion, the decision to change the oxygenator was made and initiated after a renewed bga check.After the change, all bga parameters have normalized.At 6 l/min arterial blood flow and 100% fi02, the patient's oxygen partial pressure was 86 mmhg, with a bilateral nirs (near infrared spectroscopy) values of less than 35% and a venous saturation of 45%.Intraoperative exchange of the heart-lung machine.The patient could not be adequately oxygenated for a period of approximately 30 minutes (beginning of oxygenation deterioration until the decision was taken to exchange the hlm).The situation quickly improved after the exchange of the hlm.Whether the incident has an impact on the postoperative course was currently unclear.No consequence or impact to patient.Product was changed out.Procedure was completed successfully.

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 may 24, 2022.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.

Event Description

Additional information received based on the translation in page 6 of the perfusion protocol, stated that the blood pressure of the patient was within the normal range before and after the antegrade cerebral perfusion.The venous saturation was consistently above 65% and the exchange of oxygenator was from 01:38 pm until 01:39 pm.The fio2 values were, upon the pump was on at 10:54 am was 100%, from 11:00 am at 83%, from 11:11 am at 62%, from 12:10 pm until exchange of hlm at 100% and exchange of hlm at 01:38 pm.As for the information to the hlm, it was stated that an oxygen/air supply was not employed via a wall source, nor a tank source.

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: d4 (additional device information - added exp 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 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 returned sample was visually inspected upon receipt with no break or other anomalies that could lead to the decrease in the gas transfer performance.After having been rinsed and dried, the actual sample was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, no anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory's control criteria.The evaluation verified that the actual sample, after rinsed, met the specified gas transfer performance with no anomaly observed.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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14487605
• MDR Text Key: 300442183
• Report Number: 1124841-2022-00114
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

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 Expiration Date: 01/31/2024
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: ZD01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 05/19/2022; 07/19/2022
• Supplement Dates FDA Received: 06/07/2022; 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2024
• 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
• Treatment: HL20 MARQUETT
• Patient Weight: 120 KG