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

Catalog Number CX-FX05RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k) no: k130280.The actual sample was received for evaluation.Visual inspection did not reveal any anomalies, such as a break, in the appearance.The actual sample, after having been rinsed and dried (page 3), was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol: bovine blood arranged to (hb12.0 g/dl, temp.37oc., ph:7.4, svo2:65% and pvco2:45mmhg) was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 2l/min.And 1/min.Result: o2 transfer vol.: @2l/min.= 120ml/min.@1l/min.= 65l/min; co2 removal vol.: @2l/min.= 92ml/min.@1l/min.= 55ml/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 involved product code/lot number combination revealed 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 flow rate.To decrease pao2, increase the total gas flow.To increase pao2, decrease the 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 a cause of the reported issue (decreased pao2 and increased pco2) the factors below can be inferred.Rewarming activated the patient's metabolism and blood of which so2 had been lowered and pco2 had been increased flowed into the oxygenator.Administration of a drug which contained sodium bicarbonate led pco2 in the blood flowing into the oxygenator to be increased.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 during the procedure.Around 4 and half hours after the initiation of the circulation, the gas transfer performance (o2 transfer and co2 removal) got deteriorated.The actual sample was not changed out.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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 4103927866
• MDR Report Key: 8905346
• MDR Text Key: 157873686
• Report Number: 9681834-2019-00145
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071572
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 190301
• 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: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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