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
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.E3: occupation: chief perfusionist.G4: pma/510(k): k130520.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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.Maufacturing date: april 19, 2024.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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 information was received on 30oct2024: initially it was reported there was an issue with plasma-leakage, however the actual issue was 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 fibre wall.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to provide the completed test results.Visual inspection of the actual sample upon receipt: no breakage or similar anomaly was observed in the appearance.The gas exchange part was discolored.This was likely to have been caused by the hydrophilization of fibers.Liquid was accumulated on the gas inlet side.There was no blood adhering to the gas channel side.Leakage test of the actual sample the actual sample was incorporated into a circuit consisting of tubing and primed with saline solution.Subsequently, the saline solution was replaced with bovine blood (hb:12g/dl, 37) , and circulation at the maximum flow rate of 7l/min was performed.As a result, no blood leak was observed.Cause of occurrence/conclusion the blood leak that was pointed out in this case was not confirmed during the investigation of the actual sample.Based on the condition of the actual sample upon arrival at the factory, it was believed to be a plasma leak caused by the hydrophilization of the fiber.We have experienced instances where liquid (plasma component) flows out to the gas outlet side (plasma leak) when fiber is hydrophilized due to certain factors.In addition, when blood is hemolyzed, reddish plasma may flow out.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.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: 20641954
• Report Number: 9681834-2024-00194
• Device Sequence Number: 12618014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• 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: 10/23/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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