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

Catalog Number CX*FX15RE40

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Review of the blood gas data: information on blood flow rate or bsa was not provided for the investigation.(data 1) at the start of extracorporeal circulation, po2 was 74.2 mmhg, so2 was 94.2% and fio2 was 100%.(data 2) at 9:47, po2 was 296.8 mmhg, so2 was 99.9% and fio2 was 80%, indicating a decrease in fio2.The gas flow rate was reported as 0.5 l/min.(data 3) at 9:53, when the po2 had dropped to 51.2 mmhg, the so2 was 85.9%, indicating that the so2 decreased.The gas flow rate at this time was reported as 3 l/min.It should be noted that the fio2 was increased at 9:53; however, since the oxygenator was changed afterwards, the changes in svo2 could not be confirmed from the blood gas data.Based on the above, one of the possibilities is that svo2 decreased and po2 decreased due to insufficient oxygen supply or blood flow rate to the patient at 9:47.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.It is likely that the fio2 was not 100%, so the oxygen supply was insufficient; the gas flow rate was insufficient for the blood flow rate because v/q was not equal to 1.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported the capiox device was used during the procedure.When the patient started doing extracorporeal circulation with fx oxygenator (lot: 191202k), the po2 was 74.2 mmhg.The flow rate was increased 0.5 l/m and po2 is 296.8.And po2 was suddenly dropped to 51.2 mmhg only at flow rate 3 l/m.The color of blood in output of oxygenator was black, and hospital decided to change to a new fx oxygenator.The po2 recovered and reached 520.2 mmhg new fx oxygenator.The doctor observed a blue color of arterial blood immediately after running process.The patient was not harmed.The procedure outcome was not reported.

• Brand Name: CAPIOX FX 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; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 12015264
• MDR Text Key: 256701283
• Report Number: 9681834-2021-00110
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701107
• UDI-Public: 04987350701107
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CX*FX15RE40
• Device Lot Number: 191202K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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 Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 59