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 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510(k)- k130280.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.For 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 involved capiox device was used during the procedure.Bsa 1.72.Blood gas test result with cdi500, 50 minutes after pump started: blood flow 4.2l, gas flow 2.5l, fio2 60%, pao2 around 250, and co2 around 50.After that, co2 increased to 80 while pao2 did not change.In order to decrease co2, another fx25 was added to return blood to the reservoir, however it could not be decreased as expected (from 80 to 70 only).After the first oxy was removed, circulation continued with the second oxy only, and pao2 and co2 became stable.No pressure drop was observed during ecc.Second fx25 was added to the arterial side.Oxygenated blood was returned to the reservoir and then pumped through the first oxy.After that, the first oxy was removed and circulation was done with the second oxy only.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed no break or no other obvious anomaly that could lead to the reported drop in oxygenation performance.The actual sample, after having been rinsed and dried, was tested for its o2 transfer and co2 removal 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 manufacturer specifications.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= 395 ml/min.@4l/min= 282 ml/min; co2 removal volume: @6l/min= 326 ml/min.@4l/min= 245 ml/min.Review of the pump record involved in this complaint revealed: from the start of circulation at 10:31 to 11:30, pco2 value in the blood gas data increased significantly from 45.5 mmhg to 80.4 mmhg, while in the cdi500 data it was around 40 mmhg during the period.After the gas flow was increased from 1.5 l/min to 10 l/min, pco2 value in the blood gas data decreased to 70 mmhg, while in the cdi500 data it increased from 38 mmhg to 70 mmhg.Ifu sates: 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.As it was reported that no anomaly was observed in the po2 value, it is unlikely that only the co2 removal performance would deteriorate due to the deterioration of the gas exchange performance of the oxygenator.It is likely that the blood with increased pco2 might have been flowing into the oxygenator for some reason; since the discrepancy in pco2 value transition was observed between the blood gas data and the cdi500 data, it is likely that malfunction of blood gas meter or cdi500 might have occurred for some reason.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 11063893
• MDR Text Key: 234258107
• Report Number: 9681834-2020-00263
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: CX-FX25E
• Device Lot Number: 200618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other