MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX25RW

Device Problem Air/Gas in Device (4062)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided age & date of birth: requested, not provided patient sex: requested, not provided weight: requested, not provided ethnicity: requested, not provided race: requested, not provided implanted date: device was not implanted explanted date: device was not explanted pma/510(k): k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.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.(b)(4).

Event Description

The user facility reported that the capiox device was used during the procedure.The oxygenator bubbled during cec with a temperature of 32 degrees with all vent outlets open was necessary to press with a sterile compress so as not to lose too much oxygenator volume.The tca stood at 620.Blood gas analysis was good, and the patient was not injured.It was an aortic valve replacement mitral and tricuspid, 120 minutes of cpb in total.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.The provided image and the video at the time of occurrence was confirmed.Following results were obtained: air bubbles were flowing out from the upper side of venous filter.The cap is not connected to the port (1/4" - 3/8" port) next to the venous blood inlet port.Visual inspection of the actual sample revealed no anomaly including a breakage in its appearance.There was no return of the blue cap etc.Attached to each port at the upper side of reservoir.Simulation test: after rinsing the actual sample it was installed into a circuit consisting of tubes, and the defoaming performance of venous filter was investigated by bovine blood.No air bubbles flowed out on the liquid level, and the event indicated in the ppr was not reproduced.In order to investigate the defoaming performance of venous filter, a factory-retained cap was connected to each port of the actual reservoir.From past experience, it has been confirmed that when air continued to enter the venous line due to blood removal failure or loosening of the yellow cap at the venous blood inlet port, air bubbles flowed out from the upper side of the venous filter of reservoir.Therefore, after inspection of the actual sample, while circulating bovine blood, air continued to be mixed from the venous line.As a result, the phenomenon that air bubbles flowed out from the upper side of venous filter was simulated.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, and the air bubbles that could not be completely defoamed by the defoamer overflowed from 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.Ifu states: make sure the caps of unused luer ports are tightened firmly to prevent the leakage.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.No anomaly leading to the generation of air bubbles was found in the actual sample after rinsing.As a possible cause of the blood flowing out from the upper side of reservoir, it was likely that since air continued to be mixed from the venous line for some reason, air bubbles accumulated inside the venous filter, and the air bubbles overflowed from the upper part of venous filter.From the available information, however, the cause of occurrence could not be clarified.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12539136
• MDR Text Key: 273546430
• Report Number: 9681834-2021-00161
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 200402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1