MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX15RW40

Device Problem Gas Output Problem (1266)

Patient Problem Respiratory Insufficiency (4462)

Event Date 09/08/2022

Event Type  Injury  

Event Description

The user facility reported that the patient arrived at the block desaturated (sa02 88%) on long term peripheral veno-venous ecmo in terminal ventilatory failure.The patient had a potts anastomosis on (b)(6) 2022.Start of the assist ecmo at 17:06.Od/aorta cannulation.Ecmo clamped within the first minute.No drainage difficulties.Flow is assured.Low svo2 (<60%) is reported in the first quarter of the hour.Arterial saturation and po2 are normal at this time compared to baseline gas flows (1.5l/min at 50% for a theoretical flow of 3.55l/min).Svo2 improves as the potts is controlled, to about 72%, then stabilises at 65%, despite cooling, polytransfusion, overflow and a po2 of 200mmhg.Blood pressure is normal, lactate levels remain low until the last hour of ect.The patient had no diuresis, but we noted at the end of the procedure that the urinary catheter was disconnected from the receptacle.The target core temperature was 30 degrees celsius due to the difficulty and length of the procedure.This temperature was slow to be achieved, which was attributed to the patient's anatomical surgical peculiarity.The patient's lungs were explanted.The first lung (right) is implanted.I progressively increase the gases during the cec, until i reach, after 5 hours, abnormally low biological values for very high parameters (po2 100mmhg for 100% of fio2, 8l/min of sweep.The patient's capnia remains acceptable.The surgeons and the anaesthetist are informed of a real problem linked to the oxygenator, on several occasions.Central ecmo was considered but not implemented.We are at the stage of implantation of the left lung.A malfunction of the mixer (sechrist) is excluded, the problem persisting with the gases connected to a 12 then 15 litre o2 cylinder.The membrane was inspected and flushed with fresh gas several times.Immediate action: in agreement with the anaesthetist, ventilation is resumed on the right lung, venous return is controlled, the heart ejects despite the surgical constraints.The remainder of the procedure (the last two hours) was performed at 30% of the patient's theoretical output, which allowed us to maintain and tolerate her sa02 at 90-93%, despite the 60/70mmhg po2 measured in the post-membrane (oxygenation certainly coming exclusively from pulmonary ventilation).We finished the bypass at 10 litres of principle o2.At 6h of cec, we note the excess of water (condensation? water from the thermal group?) at the entrance of the oxygenator.The excess water flows out of the orifice under the oxygenator, much more during air flushes, but it reforms almost immediately.The start of the rewarming of the patient is undertaken at 22:16, which of course increased the problem.It was very difficult, past 33 degrees celsius to achieve normothermia at only 30% flow.The surgeon did not envisage the placement of the bypass graft and haemostasis at this temperature.As a demonstration of the seriousness of the problem, and the impossibility of warming the patient more effectively, i return for a moment to a flow rate of 70% (02 to 10 litres/min).The patient spontaneously desaturates at 65%, on both lungs at this point.I immediately slow down the venous return and put the flow back to 30%.The bypass was finally placed without difficulty at 00:06, after exactly 7 hours of assistance.Severe hypoxemia, need for early graft reventilation (d lung).

Manufacturer Narrative

Expiration date: udi: n/a as this product is a bulk unit.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter: healthcare professional: unknown.Initial reporter occupation: others.Pma/510(k) - k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.As of october 12, 2022, the actual sample has not been received by ashitaka factory yet.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot#: combination.(b)(4).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide the sample receipt date in section d9, to update section h3, and to provide the completed investigation results.H6: investigation findings - 114 is based upon the evaluation of user facility information; 213 is based upon functional testing of the returned sample.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information; 67 is based upon functional testing of the returned sample.Investigation of the actual sample: visual inspection of the actual sample upon receipt did not find any anomaly such as a breakage that could lead to the 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 manual.It was confirmed to meet the factory's specifications.[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg [circulation conditions] blood flow rate: 5l/min and 3l/min, v/q:1, fio2: 100% [o2 transfer volume] @5l/min: 304ml/min., @3l/min: 202ml/min [co2 removal volume] @5l/min: 256ml/min., @3l/min: 176ml/min record review: no pump record was obtained.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found.As a cause of occurrence, following factors were inferred from the information.However, since no anomaly was found in the gas transfer performance of actual sample, it was not possible to clarify the cause of this complaint.· as a cause of the low svo2 at 15minutes after the start of circulation, according to information, it was inferred that it occurred due to the low blood flow rate relative to the patient's body surface area or the patient's condition.· rewarming was started 5 hours after the start of circulation.From the information "fio2: 100%, gas flow rate: 8l/min, flow rate: 30%", it was inferred that the blood flow rate was low at this time.· it was inferred that water droplets accumulated in the fiber due to the wet rung phenomenon, which hindered gas transfer performance.Instructions for use (ifu) states: (i) start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.(c.Intiation of bypass warnings) measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.- to decrease pao2, decrease fio2.- to increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.- to decrease paco2, increase total gas flow.- to increase paco2, decrease total gas flow.(d.During perfusion) (ii) upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing in patients metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.(precaution).(iii) a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 15 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX15 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15672766
• MDR Text Key: 302432115
• Report Number: 9681834-2022-00217
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: ZZ*FX15RW40
• Device Lot Number: 201130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• 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): Required Intervention; Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 47 KG