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

Model Number	CX*FX25E
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: ccp.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.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the caipox device involved was damaged.The event occurred out of the box.The event did not result in a delay in the surgical procedure.
Additional 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.Visual and magnifying inspections of the actual sample found a crack was found in the connecting part between the female connector and tubing on the sampling line connected to the oxygenator blood outlet port.The surface of female connector had some marks, and the female connector was also found to have cracks.Leak test of the actual sample found the colored saline solution was flowed into the actual sample by a head.As a result, leakage was found from the crack.X-ray fluoroscopic inspection of the actual female connector found that the tube inside the female connector was also found to have cracks.Simulation test: an impact load was applied to the female connector of current product.As a result, it was found that a crack similar to the actual sample appeared.X-ray fluoroscopic inspection of the cracked sample was performed.It was found that the crack similar to the actual sample was simulated on the tube inside the female connector.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, it was confirmed that a crack was found in the connecting part between the female connector and tubing on the sampling line.As a possible cause of the crack on the tube, it was inferred that some impact load was applied to the female connector that exceeding the limit strength of product.However, from the condition of actual sample, it was not possible to clarify exactly when the crack occurred.The instructions for use (ifu) (capiox fx25) has the following cautions: "do not use if the package or device is damaged (e.G., cracked) or any of the port caps are off." "if the product is dropped during set-up, do not use it.Replace with another device.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide a correction to sections d1: brand name, d4: model number, d4: catalog number, d4: lot number, d4: expiration date, d4: udi, and h4: device manufacture date.The udi was updated to match the correct format.Due to internal review, a correction was made to section d3.

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18399246
• Report Number: 9681834-2023-00268
• Device Sequence Number: 14146572
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: (01)04987350701060(17)251031(10)221114
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2023

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
• Device Expiration Date: 10/31/2025
• Device Model Number: CX*FX25E
• Device Catalogue Number: N/A
• Device Lot Number: 221114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 08/08/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/25/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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