MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HALLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: establishment address: unknown.E2: health professional: unknown.E3: occupation: unknown.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 complaint has been received.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 plasma leaked from the involved oxygenator.The event occurred during cardiopulmonary bypass.It was unknown if the event resulted in delay in beginning or continuing the surgical procedure.The product was not changed out and it was unknown if the surgery was completed successfully.The product did not cause or contribute to an injury.It was unknown if there was any blood loss.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update to section d9, and to provide the completed investigation results.No actual sample was returned.Manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar complaint has been received.As a possible cause of occurrence, from our past experience, the following factors were inferred.However, since the actual sample could not be investigated, it was not possible to clarify the cause of plasma leak.It is possible that the blood properties changed due to some factor, leading to the production of a substance having surface-active properties.This could have disrupted the relationship between the surface tension of blood and gas that had been maintained in the micropores of the fiber.As a result, the fiber became hydrophilic, causing plasma leakage.The instructions for use (ifu) (capiox fx15) indicates as follows regarding leakage: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir.".

• Brand Name: CAPIOX FX 15 HALLOW FIBER OXYGENATOR AF
• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 19807686
• Report Number: 9681834-2024-00131
• Device Sequence Number: 18023707
• Product Code: DTZ
• UDI-Device Identifier: 04987350701206
• UDI-Public: (01)04987350701206(17)261031(10)231115
• Combination Product (Y/N): N
• 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): 07/23/2024

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: N/A
• Device Catalogue Number: CX*FX15W
• Device Lot Number: 231115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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 Sex: Unknown