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

Catalog Number CX-XRX25201

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Weight - (b)(6).Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The patient's height: 181cm and bsa: 2.06m2.The actual sample was received for evaluation.Visual inspection revealed that the actual sample did not have any obvious anomalies, such as a break that could lead to poor gas transfer performance, in the appearance.The actual sample, after rinsed and dried, was tested for its o2 transfer and co2 removal performance in accordance with the factory's shipping inspection protocol.Blood conditions: bovine blood arranged to hb:12.0g/dl, temp.:37°c; circulation conditions: flow rate: 6l/min.And 4l/min., v/q: 1, fio2:100%; result: o2 transfer: @6l/min.: 397ml/min.@4l/min.: 286ml/min; co2 removal: @6l/min.: 328ml/min.@4l/min.: 236ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.Reproductive testing was performed with the actual sample simulating the situation where pao2 decreased at 8:38 and pao2 increased at 8:45.At 8:38 when pao2 decreased.Bovine blood arranged to the same blood condition as those of the blood gas data read at 8:38, was circulated in the rinsed actual sample under the below circulation condition.Blood flow rate: 4.48l/min, gas flow rate: 3.56l/min, hb: 12.3g/dl, and fio2: 76.3%.When svo2 was 58%, pao2 was 102mmhg, which was close to 105.3mmhg read at 8:38.When fio2 was 100%, pao2 was found to be 279mmhg.Circulation condition at 8:36: blood flow rate: 4.68l/min, gas flow rate: 3.56l/min, hb: 12.3g/dl, fio2:76.3%, blood temp.: 36.6°c.At 8:45 when pao2 increased.Bovine blood arranged to the same blood condition as those of the blood gas data read at 8:45, was circulated in the rinsed actual sample under the below circulation condition.Blood flow rate: 4.69l/min, gas flow rate: 3.36l/min, hb: 11.7g/dl, and fio2: 89.8%.When svo2 was 58%, pao2 was 220mmhg, which was close to 223.63mmhg read at 8:45.Circulation condition at 8:45: blood flow rate: 4.69l/min, gas flow rate: 3.36l/min, hb: 11.7g/dl, fio2:89.8%, blood temp.: 36.6°c.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Review of the pump record involved in this complaint obtained revealed that the pump was on at 03:18 with flow rate of 3.00l/min, gas flow rate of 1.94l/min, and fio2 of 58.4%.At 4:21, circulation was partially stopped.At 6:27, full flow was started.From 8:10 (in five hours after pump on) to 8:38, pao2 decreased from 218mmhg to 105mmhg and fio2 was changed from 76% to 90%.Afterward, pao2 increased up to 223.6mmhg.At 3:49, cooling started.At 3:52, arterial temperature was found to have decreased to 19.3°c.From 3:52, arterial temperature was increased gradually up to 36.0 °c around 7:00.Pao2 stared to decrease at 7:19.At 11:01, the oxygenator was exchanged.At 11:06, blood flow rate: 4.50l/min, fio2:53.9%.At 11:12, pao2 368.4mmhg.Considering that fio2 at 8:42 was 89.8% and pao2 at 8:45 was 223.6mmhg, it is assumable that that gas transfer of the actual sample had been obstructed due to some factors.Based on the findings, it is likely that svo2 decreased due to increasing o2 consumption volume caused by the patient's metabolism having been activated by the rewarming.In addition, gas transfer might have been obstructed due to some factor.Ifu states: 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.Start gas supply with v/q=1 and fio2=100%, then make adjustments based on blood gas measurements.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.A phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.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 water drops were generated due to the wet lung phenomenon, resulting in preventing the gases from being transferred sufficiently; the fio2 set during the event was insufficient for the patient's o2 consumption, resulting in the decreasing svo2, and then decreasing pao2 accordingly; or 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, 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 there was no problem was observed at the beginning of the procedure with the involved capiox custom pack.The oxygenation performance begun to decrease after five and half hours after the pump was on.The actual sample, after a long time run appeared to not be offering oxygenation performance sufficiently for the patient's physique.The actual sample was 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; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 9664533
• MDR Text Key: 191794028
• Report Number: 9681834-2020-00003
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: CX-XRX25201
• Device Lot Number: 190607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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; Required Intervention
• Patient Weight: 85