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

Model Number	CX*FX05RW
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: others g4: pma/510(k): k130280 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.The manufacturing record and the shipping inspection record of the actual product · no anomaly was found.Past complaint file · no other similar report of the product with the involved product code/lot# was found.Manufacturing date: november 7, 2023 terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user reported that they had an unexplained oxygenator de-prime today.There was no harm to the patient.It occurred during post-bypass ultrafiltration (modified ultrafiltration).The perfusionist re-primed the oxygenator and it occurred again.Cause unknown.The procedure outcome was not reported.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual inspection of the actual sample no anomaly such as damage was found.After rinsing the actual sample, circulation was confirmed using colored saline solution.No anomaly such as leakage that could lead to the air mixing was found.The actual sample was circulated for 6 hours.No air mixing was found.Simulation test: based on the information that air was mixed "during post-bypass ultrafiltration", a branch line for ultrafiltration was installed on the outlet side of actual sample, and the following simulation test was performed.The test conditions were set arbitrarily.The roller pump was rotated with the branch line flow rate at 0.5 l/min in the condition of the main flow rate at 0 l/min.As a result, it was found that the oxygenator became in negative pressure and air got mixed in.The roller pump was rotated with the branch line flow rate at 1.0 l/min while circulating at a main flow rate of 1.5 l/min.As a result, it was found that the oxygenator became in negative pressure and air got mixed in.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found.Past complaint file: no other similar report of the product with the involved product code/lot# was found.Manufacturing date: november 7, 2023.Cause of occurrence/conclusion: based on the investigation result, no anomaly that could lead to the air mixing was found in the actual sample.As a cause of this case, based on the information that air was mixed "during post-bypass ultrafiltration", it was likely that there was no air mixed in when circulation started.Therefore, it was inferred that the ultrafiltration pump etc.Created negative pressure inside the oxygenator, drawing air through the fiber.However, since the circuit specifications and circulation conditions at the time of use were unknown and no anomaly was found in the actual sample, it was not possible to clarify the cause of occurrence.Relevant ifu reference: to prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 0.5l/min.During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX®FX
• 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: 20738081
• Report Number: 9681834-2024-00204
• Device Sequence Number: 8362729
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)261031(10)231107
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071572
• 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): 11/20/2024

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*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 231107
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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