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 Information (3190)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

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 decision control sheet of the involved product code/ lot # combination was conducted with no findings.Regarding the fiber lot having been used for this product code/ lot #, the gas-transfer performance test conducted in the shipping inspections showed that this fiber lot satisfied the manufacturer specification.The pump record involved in this complaint was not available for review.Ifu states: upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Based on the complaint description that the user experienced the oxygenation problem while continuously rewarming to 37°, it is likely that the volume of supplied o2 became insufficient for the o2 consumption volume that increased due to the patient's metabolism activated by the rewarming, resulting in a decrease in svo2.However, since the patient demographic (bsa, height) and the circulation condition (flow rate, fio2) were unknown, and with no return of the actual device, 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 involved capiox device was used during the procedure.While on cardiopulmonary bypass, after removal of the cross clamp and continuously rewarming to 37 degrees, they experienced a problem with oxygenation.The perfusionist checked the possible cause; the blood flow was on 2.4 cardiac index and they confirmed that the gas supply was securely connected to the oxygenator.They changed the source of oxygen with a new oxygen tank; however, there was still a persistent hypoxemia despite of alternative o2 supply.The arterial blood of the patient became black in color meaning there was not enough oxygen in the blood.The patient and 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 10055769
• MDR Text Key: 196787196
• Report Number: 9681834-2020-00078
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 191111K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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; Disability
• Patient Age: 51 YR
• Patient Weight: 70