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

Catalog Number CX-XRX29103

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual device was received for evaluation.Since the involved patient was staphylococcus aureus positive, the actual sample was subjected to visual inspection only.Visual inspection revealed no anomalies, including a break or adhesion of a foreign substance, which could have been a trigger of the reported poor gas transfer performance.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 perfusion record from the involved procedure: the patient was 170cms tall and weighing 70kgs with the body surface area 1.81m2.According to the complaint description, they increased the gas flow rate up to 10l/min.On the record, the gas was increased to 10l/min at 1:30.The blood flow rate around 1:30 (1:00- 1:44) was 4.28 - 4.64l/min.From this, "insufficient blood flow rate" can be eliminated from possible causes of the reported poor gas transfer performance.The blood gas analysis at 0:43 (10 minutes after the initiation of rewarming) showed pao2 was 395mmhg and fio2 was 80%.The next blood gas analysis at 1:15 showed pao2 was 249mmhg, paco2 48.2mmhg, fio2 100% and the gas flow rate was 8l/min.The next blood gas analysis was conducted at 1:30.Pao2 was 131mmhg, paco2 50.1mmhg fio2 100% and the gas flow rate was 10l/min.The recorded data show that even with fio2 being 100%, pao2 got decreased and that with an increase in the gas flow rate, paco2 went up.From these findings, it is assumable that some factor(s) which led the gas transfer performance to get deteriorated occurred between 0:43 and 1:30, after the initiation of rewarming.To see if there was any anomaly in the involved fiber lot#, the result of the gas transfer performance test conducted on the product (rx25) in which the involved fiber lot# had been built during the shipping inspection process before the unit release from ashitaka factory was reviewed.The gas transfer performance (o2 transfer volume and co2 removal volume) was confirmed to meet the manufacturer specifications; blood conditions: hb:12g/dl, temp.37oc, ph:7.4, svo2:25%, pvco2:45mmhg; circulation conditions: v/q=1, fio2=100%, flaw rate:6l/min.And 4l/min; o2 transfer volume: @6l/min.= 391ml/min.@4l/min.= 288ml/min; co2 removal volume: @6l/min.= 313ml/min.@4l/min.= 254ml/min.Ifu states: 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 20l/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.It is likely that the wet-lung phenomenon occurred inside the gas transfer module of the actual device, where water drops accumulated inside the fibers, which hampered blood from having enough contact with o2 gas, resulting in the deterioration of the gas transfer performance; rewarming activated the patient's metabolism.By this o2 consumption volume was increased, leading to a decrease in svo2 and a decrease in pao2; rewarming accelerated dilatation of the peripheral vessels and blood of which so2 had been lowered flowed into the oxygenator, resulting in a decrease in svo2 and 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 capiox custom pack was used during the procedure.During rewarming, pao2 decreased.The gas flow rate was increased to 10l/min.With fio2 being 100%, however, pao2 stayed a little more than 100.The patient was weaned off bypass safely.The device was not changed out, the procedure outcome was not reported.The patient was not harmed.

• 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: 8905344
• MDR Text Key: 159193230
• Report Number: 9681834-2019-00142
• 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: 08/19/2019

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: 09/30/2020
• Device Catalogue Number: CX-XRX29103
• Device Lot Number: 190410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• 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 Weight: 70