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

Model Number	CX*FX05RW
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k130280.The actual sample has not yet been received by ashitaka factory.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 was found of the past complaint file of the involved product code/lot number.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 blood inlet port on the capiox fx05 appeared deformation.The procedure outcome was not reported.The final patient impact was not harmed.
Additional Manufacturer Narrative
Visual and magnifying inspection of the actual sample found that the blood inlet port was deformed from the outside to the inside.Visual and magnifying inspection of the blue cap that had been attached to the blood inlet port of the actual oxygenator sample found damage on the outer surface and a trace of contact with the blood inlet port on the inner surface.From this, it was inferred that the blood inlet port was exposed to some load at some point after the blue cap was attached to it.Simulation test: a load was applied to a blood inlet port of an oxygenator, as if something hard had hit it.As a result, the blood inlet port was crushed from the outside to the inside.According to the results of the investigation, it was considered that the deformed blood inlet port of the actual sample might have been caused by an application of some load.As the blue cap is attached to the blood inlet port after 100% visual inspection in the manufacturing process, it was likely that the actual sample was exposed to some load after the blue cap was attached and deformed.However, the timing when such a load was applied could not be clarified from the condition of the actual sample.Relevant instructions for use (ifu) reference: "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, and d4: udi.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 ; 6402040886
• MDR Report Key: 18091816
• Report Number: 9681834-2023-00217
• Device Sequence Number: 6670307
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)260131(10)230208
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2023

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: 01/31/2026
• Device Model Number: CX*FX05RW
• Device Catalogue Number: N/A
• Device Lot Number: 230208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 08/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/30/2023; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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 Age: 4 YR
• Patient Sex: Male