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

Catalog Number	CX*FX25RE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)-k130520.The actual device has 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 decision control sheet of the involved product code/lot# combination was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that the capiox device connector of sample line could not be fixed, easy to dis-connect during the priming.The event occurred pre-treatment, the patient was not harmed.The procedure outcome was not reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update to the device return date in section d9, update section h3, and to provide the completed investigation results.It was initially reported that the actual device was available.However, only one sample was returned for report 9681834-2021-00215; therefore, the evaluation for that device was performed for this report as well.The actual sample was received for evaluation.Visual inspection of the actual sample revealed that the lock adapter had come off the male connector of the sampling system.Magnifying inspection of the actual sample did not find any anomaly including a deformation in the male connector or in the lock adapter.The outer diameter of the rib of actual male connector was measured and was compared with a factory-retained product.No difference was found.The surface of actual male connector was subjected to elemental analysis by sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).As a result, si was detected, which was likely to be derived from the silicone applied to the cock of three-way stopcock for the purpose of improving lubricity.Simulation test: as a simulation test, after applying silicone to the male connector of factory-retained sampling system, the female connector was connected and applied torque force to the lock adapter.It was found that the lock adapter was come off.As a factor that silicone adhered to the male connector, it was inferred that silicone transferred from the cock.However, as a result of further investigation, it was found that not only physical contact but also vaporized silicone in the storage container had an influence.Product structure: the sampling system is designed so that the internal step of lock adapter is caught on the ribs of male connector to prevent loosening when the female luer is fixed.Therefore, if the internal step completely overcomes the ribs for some reason, the fixing may come off.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.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 was likely that the silicone applied to the cock of sampling system for the purpose of improving lubricity was transferred to the male connector for some reason (physical contact or the influence of vaporized silicone), and when the lock adapter was tightened, it came off.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: 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: 12907515
• Report Number: 9681834-2021-00216
• Device Sequence Number: 19853975
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 210210
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown