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

Catalog Number CX-XRX43002A

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

510k: k130520.The actual sample was received for evaluation.Visual inspection revealed no visible anomaly including a break in it.As a result of blowing air into the gas channel, liquid was observed on the gas outlet side.The liquid was collected and checked with terumo's protein test paper.Presence of protein was confirmed in the liquid.The liquid was centrifuged.As a result, no sedimentation of blood cell components was found in the liquid.The actual sample was built into a circuit.Physiological saline solution was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to be slightly higher than those obtained from a current product sample.Review of the pump record did not find any indication that could lead to the plasma leak.After the actual sample was rinsed.The fiber from the outer and inner layer was inspected under electron microscope.There was no difference in the state of micro pore between the actual sample and a current product sample.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: 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.The investigation results verified the returned sample was of the normal product.It is likely that due to a change in the blood properties a surface-active substance may be generated in blood.This may lead the balance of the surface tension between the gas and blood which is kept at the micro pores on the surface of the fibers to be upset, and the fibers got hydrophilized, resulting in plasma leak; or the pressure inside the oxygenator module raised by some factors, such as clotting, may cause the pressure applied from the blood channel to the gas channel to get increased, this may create the circumstances where force to push the blood corpuscle components out into the gas phase may increase and plasma component could easily leak out through the micro pores on the surface of the fibers to the gas channel.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 the involved capiox custom pack was used during a thoraco-abdominal vascular replacement case.A plasma leak occurred when ecc time exceeded six hours.The gas transfer performance dropped; the pressure at the outlet port of oxygenator increased.They replaced the device with a cx-fx25rw40v to complete the ecc.Estimated blood loss was 260ml.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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 9207140
• MDR Text Key: 173807296
• Report Number: 9681834-2019-00175
• 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: 10/18/2019

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-XRX43002A
• Device Lot Number: 190603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• 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