MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.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.Before clamping the aorta, the operator found the color of arterial blood was dark and same as venous blood, the operator checked all the points, and did not find the reason.The operator replaced the device with another one; the color and oxygen saturation became normal.The patent 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 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:12 g/dl, temp.:37°c., ph:7.4, svo2:65%, pvco2: 45 mmhg.[circulation conditions] blood flow rate: 6 l/min and 4 l/min, v/q=1, fio2=100%.[o2 transfer volume] @6l/min= 383 ml/min.@4l/min= 274 ml/min.[co2 removal volume] @6l/min= 335 ml/min.@4l/min= 243 ml/min.During the above gas transfer performance test, the color of blood was also checked.It was confirmed that the blood in the arterial line was brighter than that in the venous line.The pump record involved in this complaint was not available for review.Ifu states: start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.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.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX RX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11169115
• MDR Text Key: 226765565
• Report Number: 9681834-2020-00276
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• PMA/PMN Number: K040210
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 200226C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 65