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

Catalog Number CX*RX25RW

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number- requested, not provided.The actual device was not received for evaluation.A movie provided by the user was reviewed and showed that foamy red-transparent liquid was flowing out from the gas outlet port of the oxygenator.Visual inspection of a factory-retained retention sample of the involved product code/lot# did not find any visible anomaly including a break that could lead to leakage.The blood channel was filled with saline solution.The blood outlet port was occluded, and then air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port.No leak was observed.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant 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 movie of the event, plasma leak was likely to have occurred during use.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 imbalanced, 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.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that about two hours later after the start of cpb, the perfusionist found liquid flow out of the capiox gas outlet.There was no harm to the patient.The procedure outcome was not reported.

• Brand Name: CAPIOX RX 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: 9530405
• MDR Text Key: 174515840
• Report Number: 9681834-2019-00226
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 190725C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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
• Patient Age: 46 YR
• Patient Weight: 73