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

Model Number	CX*FX25W
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: chief perfusionist.G4: pma/510(k): k130520.The actual device is not available for return: therefore, an evaluation of the actual device was unable to be conducted.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found.Past complaint file of the involved product code and lot number one similar issue was reported from the same facility.Manufacturing date: april 19, 2024.Cause of occurrence/conclusion: 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 the reported plasma leak.The blood properties changed due to some factor, leading to the production of a substance with surface-active properties.This could have disrupted the relationship between the surface tension of the blood and the gas maintained in the micropores of the fiber.As a result, the fiber became hydrophilic, leading to plasma leakage.Relevant ifu reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir." 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 oxygenator had a plasma-leakage (fiber breakage).The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the additional information received in section b5.Based on the results of the investigation, the cause of the occurrence could not be determined because the actual sample could not be examined.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
Additional information was received on 30oct2024: the customer was complaining of fiber breakages, which would cause a blood leakage as a result and no plasma leakage.The development of plasma leakage is based on other causes, e.G.Blood plasma is able to penetrate the fiber wall.

• 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 ; 9499890491
• MDR Report Key: 20642108
• Report Number: 9681834-2024-00195
• Device Sequence Number: 20709512
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: (01)04987350701084(17)270331(10)240419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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*FX25W
• Device Catalogue Number: CX*FX25W
• Device Lot Number: 240419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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