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

Catalog Number CX*FX25RW

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed no break or no other obvious anomaly in it.The actual sample, after having been rinsed and dried, was tested for its o2 transfer volume and co2 removal volume in accordance with the factory's inspection protocol.As a result, the obtained values were confirmed to meet the factory's control criteria.No anomaly in the gas transfer performance was observed.[bovine blood conditions] hb:12g/dl, temp.:37°c., ph:7.4, svo2:65%, pvco2: 45mmhg.[circulation conditions] blood flow rate: 6 l/min and 4 l/min, v/q=1, fio2=100%.[o2 transfer volume] @6 l/min= 386 ml/min.@4 l/min= 274 ml/min.[co2 removal volume] @6 l/min= 312 ml/min.@4 l/min= 233 ml/min.Record review: review of the picture of the blood gas data revealed: the circulatory conditions were unknown.Pco2 was high at 91.6 mmhg at 13:30 (time indicated in the note).Po2 at 13:23 actual time (at 13:35 time indicated in the note) was 79 mmhg.Fio2 was 60% and po2 was 229 mmhg.Pco2 at 13:59 actual time was 58mmhg, and at 14:02 was 47mmhg.From the above data, there was no abnormality in po2 and no increase in temperature (not at the time of rewarming) a review of the device history record and the incoming inspection 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.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 results verified the returned sample was of normal product.No anomaly was observed in the po2 value.As it was most unlikely that only the co2 removal performance decreased while the oxygenation capacity was normal, it was conceivable that there was no anomaly in the actual oxygenator sample.In addition, as it did not occurred during rewarming, rewarming was not the factor of the reported issue.It is likely that he pco2 of the blood in the surgical field had increased due to co2 gas being blown into the field.When the blood containing increased pco2 and the co2 gas in the surgical field were suctioned into the reservoir, the pco in the blood in the reservoir increased, and then, the blood flowed into the oxygenator, the pco2 of bg increased.As an infusion fluid, solution containing sodium bicarbonate was added, leading to increasing pco2.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the capiox device was used during the procedure.During cpb, the perfusionist found pco2 was higher than normal value.He increased the gas flow, although the pco2 decrease slowly.The patient was not harmed.The procedure outcome was not reported.

• 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: 12505066
• MDR Text Key: 273340948
• Report Number: 9681834-2021-00158
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 201214C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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: 45 YR
• Patient Weight: 62