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

Catalog Number CX-FX15RE40V

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

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 obvious anomaly, such as a break, in the appearance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance.Bovine blood arranged to hb12.0 g/dl, temp.37deg.C., 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 flaw rate of 5l/min.And 3l/min.Result: o2 transfer: @5l/min.= 315ml/min.@3l/min.= 211ml/min, co2 removal:@5l/min.= 257ml/min.@3l/min.= 172ml/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 shipping inspection record of the involved product code/lot number combination revealed no findings.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.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 15 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: the circulation volume became insufficient against the patient's bsa, resulting in the decrease in svo2 and pao2; 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; the contact between blood and o2 gas was obstructed by blood clots, resulting in the poor oxygenation performance; or water drops were generated due to the wet lung phenomenon, resulting in preventing the gases from being transferred sufficiently.However, 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 capiox oxygenation failure occurred during treatment of vsp.After about three hours from starting the pump, pao2 would barely exceed 100mmhg.Flushing gas could not improve it.There was no pressure rise was noted.They continued using the actual device.Due to the patient's poor cardiac function, the pump could not be removed, so pcps was applied.There was no change out of the oxygenator.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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 9488370
• MDR Text Key: 199292434
• Report Number: 9681834-2019-00217
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: CX-FX15RE40V
• Device Lot Number: 190618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• 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