MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The user facility reported that the capiox device was used during the procedure.During cpb, gas exchange was not good, even if increasing gas supplying and fio2.At the same time, bubbles continue to flow out from the port (1/4-3/8 port) next to the venous inlet port.The patient was not harmed.The patient outcome was not reported.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.(b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.H6 - investigation findings: 114 is based upon the evaluation of user facility information and the provided video; 213 is based upon functional testing of the returned sample.H6 - investigation conclusions: 4310 is based upon evaluation of the user facility information and the provided video; 67 is based upon functional testing of the returned sample.The actual sample was received for evaluation.Inspection of the actual sample and data (oxygenator and gas transfer failure): visual inspection of the actual oxygenator revealed no anomaly including a 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 manual.It was confirmed to meet the factory's specifications and no anomaly was found in the gas transfer performance.[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg.[circulation conditions] blood flow rate: 6l/min and 4l/min, v/q:1, fio2: 100%.[o2 transfer volume] @6l/min: 408ml/min., @4l/min: 286ml/min.[co2 removal volume] @6l/min: 336ml/min., @4l/min: 249ml/min.1.3 the following contents were confirmed in the provided information.In the margin of blood gas data, "1" and "2" were described respectively, and the gas flow rate and fio2 at that time were described.In addition, po2 is as follows, and a decrease in po2 was observed.1) gas flow rate: 2l, fio2: 50%, po2: 134mmhg.2) gas flow rate: 2.2l, fio2: 60%, po2: 72mmhg.Items such as blood flow could not be confirmed and were unknown.[reservoir (bubbles flowed out from the 1/4" - 3/8" port)].The provided video at the time of occurrence was confirmed.It was found that bubbles were flowed out when the cap of the port (1/4 "- 3/8" port) next to the venous blood inlet port was removed.Visual inspection of the actual sample upon receipt found that the sampling line connected to the venous line was disconnected, but no anomaly such as a breakage was found in the other sections.There was no return of the parts such as a blue cap attached to each port at the top of the reservoir.After rinsing the actual sample (to investigate the filtering performance of the venous filter, factory-retained caps were connected to each port of the actual reservoir), it was installed into a circuit consisting of tubes, and the filtering performance of the venous filter was investigated with bovine blood.No air bubbles were flowed out on the liquid surface, and the event of reported issue was not simulated.Simulation test: from past experience, it has been confirmed the phenomenon that air bubbles flowed out from the upper side of the reservoir venous filter by the following mechanism.Air continued to enter the venous line due to blood removal failure or loosening of the yellow cap at the venous blood inlet port.Removed the cap connected to the port (1/4" - 3/8" port) next to the venous blood inlet port.Therefore, after while circulating bovine blood, air was mixed continuously from the venous line.As a result, the phenomenon that air bubbles flowed out from the upper side of the venous filter was simulated.As a mechanism of air bubbles flowing out from the upper side of venous filter when air was mixed from the venous line, it was inferred that the mixed air accumulated as air bubbles in the venous filter.It was inferred that after that the accumulated air bubbles overflowed from the 1/4" - 3/8" port by removing the cap connected to the 1/4" - 3/8" port.Product structure: a defoamer is attached to the inside of venous filter of the involved product.The air that has flowed into the venous filter is defoamed by the defoamer.Ifu stats: 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.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.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 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation result, no anomaly was found on the actual sample after rinsing.The following factors were inferred as the cause of occurrence.Based on the information provided, the following possibilities were inferred.However, the cause of this complaint could not be clarified.It was likely that the amount of oxygen supplied was insufficient for the amount of oxygen consumed.Due to this, svo2 was decreased, and pao2 was decreased.The gas flow rate was low for the blood flow rate.Since fio2 was not 100%, the amount of oxygen supplied was insufficient.As a cause of bubbles flowed out from the top of the reservoir, it was likely that since air continued to be mixed from the venous line for some reason, air bubbles accumulated in the venous filter, and air bubbles overflowed from the upper part of the venous filter.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX RX25 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13075108
• MDR Text Key: 286110499
• Report Number: 9681834-2021-00250
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 210420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 90 KG