MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The provided video at the time of occurrence was confirmed.It was found that the cap was not connected to the port (1/4" - 3/8" port) next to the venous blood inlet port, and air bubbles were flowing out.From past experience, it has been confirmed that the phenomenon that air bubbles flowed out from the upper side of the reservoir venous filter by the following mechanism.Air continued to enter the venous line due to blood removal failure or loosening of the yellow cap at the venous blood inlet port.Removed the cap connected to the port (1/4" - 3/8" port) next to the venous blood inlet port.As a mechanism of air bubbles flowing out from the upper side of venous filter when air was mixed from the venous line, it was inferred that the mixed air accumulated as air bubbles in the venous filter.It was inferred that the air bubbles that could not be completely defoamed by the defoamer overflowed by removing the cap connected to the 1/4" - 3/8" port.Product structure: a defoamer is attached to the inside of venous filter of the involved product.The air that has flowed into the venous filter is defoamed by the defoamer.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: ensure that all connected paths including the luer caps, the lock adapters and the port caps are securely affixed.Loose connections may cause contamination or a blood leak.It is likely that air continued to enter from the venous line for some reason, causing air bubbles to accumulate inside the venous filter, and air bubbles overflowed from the upper side of venous filter.However, with no device return 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 device was used during procedure.Less than thirty minutes after cpb start, perfusionist found lots of bubbles gush out of the auxiliary port.He changed to a new rx25rw, then everything became normal.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX RX25 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12974774
• MDR Text Key: 282034755
• Report Number: 9681834-2021-00231
• 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: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 210402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 76 KG