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

Model Number	1CX*FX25W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved oxygenator was broken.The event occurred during prime.The event did not result did not result in delay in the beginning or continuing of the surgical procedure.The location of the break was unknown, they only saw a leak during priming.Therefore, the device was changed out.The surgery was completed successfully.The event did not cause or contribute to an injury.No blood loss was reported.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted, d6b: explanted date: device was not explanted, 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 found no anomaly.No other 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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Confirmation of the provided image: it was confirmed from the image that water droplets were adhering to the oxygenator.However, it was not possible to identify the leak path.Manufacturing record and the shipping inspection record of the actual sample no anomaly.No other similar issue has been reported.Since the actual sample was not returned, and it was not possible to identify the leak path based on the provided image of the actual sample, unfortunately, the cause of the occurrence in this case could not be clarified.In order to clarify the cause, we would like to ask for your cooperation in obtaining the actual sample.The instructions for use (ifu) (capiox fx25) of ashitaka factory indicates as follows: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.".

• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 20471955
• Report Number: 9681834-2024-00189
• Device Sequence Number: 15291941
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: (01)04987350701084(17)270331(10)240425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/17/2024

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: 1CX*FX25W
• Device Catalogue Number: 1CX*FX25W
• Device Lot Number: 240425
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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