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

Model Number	CX*FX25RW
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: distributor.G4: pma/510(k): k130520.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.Manufacturing record and the shipping inspection record of the actual sample no anomaly was found.Past complaint file: no similar complaint was received regarding the involved product code and lot combination terumo medical corporation (tmc) (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 reported that once opening the package, loose part was found.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual inspection of the actual sample - it was found that the flange of l-shaped connector had been damaged.- no anomaly such as damage was found in other sections.Magnifying and electron microscopic inspections of the damaged section of actual sample - it was found that the damaged surface had been smooth.Simulation test the following simulation test was performed assuming a situation in which force was applied to the flange.A.After connecting the l-shaped connector to a factory-retained 3-way stopcock, the lock adapter was tightened.As a result, the lock adapter idled rotation and the damage of flange was not simulated.B.After connecting the l-shaped connector to a factory-retained 3-way stopcock, pushing force was applied to the l-shaped connector.As a result, the taper of the male and female connectors provided a tight fit, and no force was applied to the flange and the damage was not simulated.C.After connecting the l-shaped connector to a factory-retained 3-way stopcock, pulling force was applied.As a result, the flange of l-shaped connector was damaged.The manufacturing record and the shipping inspection record of the actual sample - no anomaly was found.Past complaint file - no other similar report of the product with the involved product code/lot# was found.Manufacturing date: august 28, 2024 cause of occurrence/conclusion based on the investigation result, as a cause of occurrence, it was likely that some force was applied to the l-shaped connector between the time the product was assembled in ashitaka factory and the time it was used, resulting in the damage.However, from the condition of actual sample, it was not possible to clarify exactly when the actual sample damaged.Relevant 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.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX®FX
• 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 blvid; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21315286
• Report Number: 9681834-2025-00005
• Device Sequence Number: 8884146
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)270731(10)240828
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 240828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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