MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE30C

Device Problem Decrease in Pressure (1490)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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, a great decrease in the performance of oxygenation occurred, due to a revision of the mitral prosthesis 90 minutes in cec.Additionally, it was necessary to increase almost to the maximum the gas exchange.They increased sweep gas flow to a higher flow as used to do during ecmo (extracorporeal membrane oxygenation) to remove the condesa.No known impact or consequence to patient.Product was not 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 september 8, 2020.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information received about the incident that states, the heart-lung machine was prepared, filled and debuffed at 07.30 am with crystalloid, colloid and heparin solutions.The tfpc connected the heat exchanger with the temperature set at 34 ° c during the debolling phase and left the circuit to circulate until the lines were cut for the cannulation.The pre-cec act was 452 seconds.The cec started at 01.03 pm, the aorta was clamped at 01.09 pm, myocardial protection saw the administration of 1000 ml of custodial cardioplegia in 6 minutes through anterograde.At the end of the cardioplegia, conventional ultrafiltration began with a total filtrate of 150 ml.Systemic flow maintained throughout the cec was 3.1 l / min (3.0 cardiac index) with a temperature of 32 ° c.At the first blood gas analytical check from the oxygenator, despite a gas flow of 3 l / min with a fio2 of 70%, the pco2 was 46 mmhg, the pao2 of 85 mmhg and the arterial saturation of 96%; the cdi was calibrated on the basis of these values.Based on a progressive worsening of the gas exchange values, displayed continuously with the cdi, the tfpc increased the washes of the sechrist up to a flow of 8 l / min with a fio2 of 90% and repeated a blood gas analysis check.Pco2 was 59 mmhg, pao2 177 mmhg and saturation 99% with an act of 528 seconds and an increase in lactate up to 6.6 mmol / l.At this point the values, displayed on the cdi, have undergone a slow improvement that has led to re-establishing a gas flow that can be superimposed on the initial one.The subsequent blood gas analysis revealed a pco2 of 31 mmhg, a pao2 of 211 mmhg and an arterial sat of 100%.The aorta was declamped at 14.17 (68 minutes) and the cec ended at 02.34 pm (91 minutes).Once the cec was over, the muf was started for a period of 15 minutes with a total ultrafiltrate of 100 ml.Diuresis was 80 ml during cec.Additionally, as per the clinical specialist, the patient was 27 kg, 145 cm which calculates to a bsa of 1.08 meters squared.At a flow index of 3.0 that would calculate to 3.24 lpm.From the information provided, the flow was 3.1 lpm and sweep gas was 3.0 lpm, fio2 was 70% with a po2 = 85, pco2 = 46.In response they increased the sweep gas to 8 lpm and the fio2 to 90%, the po2 increased to 177.The lactate level was high a 6.6 which is an indication that the adequate oxygen deliver was being maintained.The fx15 ifu recommends starting the fio2 at 100% upon initiation of cpb.The oxygenator responded appropriately to changes in sweep gas and fio2.The patient was 12 years old and may have had a high metabolic rate requiring a higher blood flow and fio2 to meet the metabolic demands (oxygen delivery requirements) of the patient as shown by a lactate level of 6.6.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected upon receipt with no anomalies that could lead to the decrease in the gas transfer performance.After having been rinsed and dried, it was then tested for its gas transfer performance in accordance with the factory's inspection protocol.No anomalies were revealed in the gas transfer performance of the actual sample with the obtained values meeting the factory's control criteria.Review of the manufacturing record and the incoming inspection record of the involved product / lot number combination confirmed there were no anomalies in them.The evaluation results verified that the actual sample, after having been rinsed, was the normal product with no issure in the gas transfer performance.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: STERILE FX15REC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10501972
• MDR Text Key: 205931211
• Report Number: 1124841-2020-00213
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450806
• UDI-Public: (01)00699753450806
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: WM08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 27