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

Model Number	CX*FX25RW
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that they had faulty packaging upon opening.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: requested, unknown.G4: 510k: k130520.The actual device was returned for evaluation.Visual inspection of the actual device it was found that the support arm had been come off.No anomaly such as damage was found in other sections.Simulation test we have experienced that when a strong impact load was applied to the product, the support arm came off.The product in the unit box was fallen freely from a height of 1.5m.As a result, the coming off of support arm was not simulated.The product in the unit box was fallen freely from a height of 3.5m.It was found that the support arm was come off.The manufacturing record and the shipping inspection record of the actual device no anomaly was found.Past complaint file no other similar report of the product with the involved product code/lot# was found.Manufacturing date: september 30, 2024.Cause of occurrence/conclusion based on the investigation result, it was found that the support arm had been come off.From the simulation test result, as a possible cause of occurrence, it was likely that during distribution or storage of the actual device, some strong impact load exceeding its limit strength was applied.However, from the condition of actual device, it was not possible to clarify exactly when the event occurred.Relevant ifu reference: "if the product is dropped during set-up, do not use it.Replace with another device." terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22096657
• Report Number: 9681834-2025-00092
• Device Sequence Number: 8022675
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)270831(10)240930
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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 Model Number: CX*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 240930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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