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	10/30/2021
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 sample was received for evaluation.Visual and magnifying inspections of the actual l-shaped female connector found that the tip flange had been damaged.No anomaly including a deformation was found in other sections.Visual inspection of the male connector on the side of the actual sampling system did not find any anomaly including a breakage.Magnifying inspection of the lock adapter on the side of the actual sampling system found that the screw thread had been deformed.Electron microscopic inspection of the damaged surface of the actual l-shaped female connector found that the fracture surface was smooth and streaky marks were observed at an edge of fracture.Therefore, it was inferred that the fracture occurred due to the force applied in the direction from the flange end to the inside.Simulation test: as a simulation test, the following confirmation was carried out assuming a situation where force is applied from the flange end to the inside.After connecting the l-shaped female connector to the factory-retained sampling system, the lock adapter was tightened strongly.As a result, the lock adapter slipped, and the flange damage was not simulated.After connecting the l-shaped female connector to the factory-retained sampling system, pushing force was applied to the l-shaped connector.As a result, the male and female connectors were tightly fitted so that no force was applied to the flange and the damage was not simulated.After connecting the l-shaped female connector to the factory-retained sampling system, pulling force was applied.As a result, damage was found on the tip flange of the l-shaped female connector.Electron microscopic inspection of the damaged surface of factory-retained damaged product found that the damaged surface was smooth and was similar to the actual sample.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.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 force in the pulling direction was applied to the l-shaped female connector from the time the product was installed at ashitaka factory to the time it was used and was damaged.However, from the state of the actual sample, it was not possible to clarify when it was damaged.The exact cause of the reported event cannot be definitively determined based on the available information.(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.

• 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: 12891797
• Report Number: 9681834-2021-00212
• Device Sequence Number: 1608432
• 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
• Report Date (Section B): 11/30/2021

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: 02/29/2024
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 210324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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