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

Catalog Number CX-FX25RWV

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2019

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed no anomalies, including a break on the device or clots formed inside the device, which could have been a trigger of the reported difficulty in the gas transfer.The actual sample, after having been rinsed and dried, was built into a circuit with tubes and tested for its gas transfer performance.Bovine blood arranged to (hb12.0 g/dl, temp.37oc., ph:7.4, svo2:65% and pvco2:45mmhg) was circulated in the actual sample under the following conditions: @ v/q=1, fio2=100% and the flow rate of 6l/min.And 4/min.Result: o2 transfer volume: @6l/min.= 391ml/min.@4l/min.= 275l/min.Co2 removal volume: @6l/min.= 305ml/min.@4l/min.= 232ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the manufacturer specifications.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.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.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 the normal product.It is likely that decreasing pao2 led to a drop in pao2; rewarming accelerated dilatation of the peripheral vessels and blood of which so2 had been lowered and pco2 had been increased flowed into the oxygenator, resulting in a decrease in svo2 and then a decrease in pao2; rewarming accelerated dilatation of the peripheral vessels and blood of which so2 had been lowered and pco2 had been increased flowed into the oxygenator, resulting in a decrease in svo2 and then a decrease in pao2.However, 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, and during the extracorporeal circulation, before rewarming, it came to be difficult to control the values of po2 and pco2.They were not able to control the gas transfer as they desired.With fio2 100% and the gas flow 10l/min., they managed to wean the patient off bypass.Since recirculation was planned 30 minutes later, the actual sample was changed out before the initiation of recirculation.With the new oxygenator, the operation was completed successfully, with no harm for the patient.The blood loss was reported to be unknown.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8909643
• MDR Text Key: 159518756
• Report Number: 9681834-2019-00144
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 190315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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