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

Catalog Number CX*FX25E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.Device manufacturer date - unknown due to unknown lot number.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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.(b)(4).

Event Description

The user facility reported the capiox device was used during the procedure.A high co2 value (60mmhg) after given cardioplegia.The high values could only be regulated with a gas flow of 8 liter.At the end of the procedure, there was also a problem with the oxygenation.Fio2 was then just enough for 130 pao2.Oxy was not part of the terumo tubing pack set.No significant delay of surgery.The patients' treatment was performed as planed and finalized.The oxy was not replaced.The procedure was completed successfully.The patient was not harmed.

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.Sections d4, and h4 have been updated.The actual sample was received for evaluation.Visual inspection upon receipt found no break or no other obvious anomaly that could lead to the decrease in the gas transfer performance.The actual sample, after having been rinsed and dried, 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.[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= 375 ml/min.@4l/min= 275 ml/min.[co2 removal volume] @6l/min= 323 ml/min.@4l/min= 241 ml/min.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.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 provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation result verified that the gas transfer performance of the actual sample after cleaned was normal meeting manufacturer control standards.In addition, no problem was found in the manufacturing-related records.Since the pump record and the detailed information were not provided, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide additional information in section h10.Patient: height: 183cm, bsa: 2.3.Review of the provided pump record revealed: circulation started at 9:26.It was stated "co2 op-feld start" at 9:28 in the event column.From this, it was confirmed that co2 gas was blown into the surgical field.From the description "kuhlen" at 9:30, it was thought that cooling started at 9:30.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.B.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.The investigation result verified that the gas transfer performance of the actual sample after cleaned was normal meeting our control standards.Based on the pump record, the following factors were conceivable as a cause of occurrence; however, from the condition of the actual sample, the cause of occurrence could not be clarified.From the information that co2 gas was being blown into the surgical field, blood with increased pco2 and co2 gas were suctioned into the reservoir, and blood with increased pco2 flowed into the oxygenator, causing pco2 value to increase.The blood temperature had been lowered, which made it difficult to remove co2.

• Brand Name: CAPIOX FX25 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: 13017307
• MDR Text Key: 284634351
• Report Number: 9681834-2021-00247
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/16/2021

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: 09/30/2023
• Device Catalogue Number: CX*FX25E
• Device Lot Number: 201021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 01/21/2022
• Supplement Dates FDA Received: 01/19/2022; 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 109 KG