MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1CX*FX25E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- perfusion director.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.A review of the device history record and product-release decision control sheet of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the capiox device oxygenator has oxygenation issues.The issue occurred during cardiopulmonary.There was no delay, the product was not changed out, no blood loss and no adverse event reported.The surgery was completed successfully.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection of the actual sample upon receipt did not find any 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.[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: 374ml/min., @4l/min: 273ml/min.[co2 removal volume] @6l/min: 312ml/min., @4l/min: 230ml/min.The following contents were confirmed in the provided additional information and pump records: it was found that the patient was 183cm tall and weighed 92kg.Since the item of blood flow rate and gas supply data (e.G.Fio2, gas flow rate) could not be found in additional information and pump records, they were unknown.11:19: at the start of cpb, svo2 was 70% and pao2 was 267mmhg.After that, svo2 gradually decreased.11:28: svo2 was 58% and pao2 was 103mmhg.11:50: svo2 was 72% and after that, svo2 gradually decreased.In addition, pao2 gradually decreased as svo2 decreased.From additional information, it was confirmed that pao2 increased to 200-300mmhg after replacing with fx25.However, since there was no description in the pump record, it was unknown when it was replaced.Ifu states: 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 investigation result, it was confirmed that the gas transfer performance of actual sample (after rinsing) met the factory's specifications.From past experience, the followings were inferred as a factor that the performance did not come out in the middle, although the performance came out at the beginning.Rewarming activated the patient's metabolism and increased oxygen consumption.Therefore, svo2 decreased and then pao2 decreased.Due to the wet rung phenomenon, water droplets were generated in the fiber and gas transfer was hindered.However, it was not possible to clarify the cause of occurrence from the condition of actual sample.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• 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: 12729330
• MDR Text Key: 279587632
• Report Number: 9681834-2021-00198
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 200213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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