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

Model Number	CX*FX15RW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2: health professional: unknown.E3: occupation: unknown.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.There was no anomaly found in the manufacturing record and the shipping inspection record of the actual sample.No similar issue has been reported.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 inlet of capiox oxygenator was broken.The product was not used in the case since the issue was identified before priming.The doctor used another terumo oxygenator.The event occurred pre-treatment; therefore, there was no patient involved or harmed.The procedure outcome was not reported.
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 inspection of the actual sample: it was found that the blood outlet port of oxygenator had been deformed.No anomaly such as damage was found in other sections.Magnifying inspection of the actual sample: it was found that the blood outlet port of oxygenator had been deformed from the outside to the inside.Therefore, it was inferred that some external force was applied to the blood outlet port.A mark was found on the inner surface of red cap attached to the blood outlet port of oxygenator, which was likely to be caused by the port coming into strong contact.Simulation test: an impact load was applied to the blood outlet port of factory-retained oxygenator.It was found that the blood outlet port was deformed from the outside to the inside.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, as a possible cause of deformation on the blood outlet port, it was likely that some external force was applied to the blood outlet port.In ashitaka factory, each cap is attached to the blood outlet port after performing 100% visual inspection.Therefore, it was inferred that the blood outlet port deformed after the cap was attached.However, it was not possible to clarify exactly when external force was applied to the blood outlet port.Relevant ifu reference: "if the product is dropped during set-up, do not use it.Replace with another device.".

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20901514
• Report Number: 9681834-2024-00223
• Device Sequence Number: 12024826
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)270331(10)240404
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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*FX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: 240404
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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