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 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number- requested, not provided.Health professional- requested, not provided.Occupation- requested, not provided.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.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).

Event Description

The user facility reported that the capiox device was used during the procedure.During perfusion there were noticeable high co2 values.The high values could only be regulated with difficulty: with a gas flow of 8-10l/min.Also, during this surgical procedure, co2 is also introduced into the open thorax (the usual procedure when the heart cavities are open to avoid air embolism later).Oxy was not part of the terumo tubing pack set.No significant delay of surgery.The patient's 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.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= 389 ml/min.@4l/min= 283 ml/min.[co2 removal volume] @6l/min= 341 ml/min.@4l/min= 249 ml/min.Ifu states: measure blood gases and make necessary adjustments as follows.B.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.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 the manufacturers control standards.In addition, no problem was found in the manufacturing-related records.From the description of the event, "during this surgical procedure, co2 is also introduced into the open thorax", it was thought that carbon dioxide gas and blood with increased pco2 might have been aspirated into the reservoir, and the blood with increased pco2 might have flowed into the oxygenator.However, 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: 168cm and bsa: 1.81.Review of the provided pump record revealed: circulation started at 8:56, it was stated "co2 op-feld start" at 9:02 in the event column.From this, it was confirmed that 1.5 l/min of co2 gas was blown into the surgical field.After that, pco2 was 100 mmhg at 9:18, confirming that the pco2 was high from the start of circulation, at 9:40, when gas flow was increased from 2.8l/min to 4 l/min, pco2 was 74.6mmhg, at 10:00, when gas flow was increased to 10l/min, pco2 decreased to 44.4 mmhg.

• 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: 13017291
• MDR Text Key: 287896851
• Report Number: 9681834-2021-00246
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• 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

• Date FDA Received: 12/16/2021
• 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
• Date Manufacturer Received: 01/21/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 71 KG