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

Model Number	CX*FX05RE
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: no patient involvement.A2: age & date of birth: no patient involvement.A3: patient sex: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: unknown.G4: 510(k) no.: 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.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
Terumo medical corporation received the following reported information: during priming, the one-way valve was found to be blocked.The event occurred pre-treatment; therefore, there was no patient involved or harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Ashitaka was informed by the local branch on 27feb2026, that the actual sample involved in this complaint was no longer available.Confirmation of the provided image: it was not possible to identify the event leading to an obstruction from the image.The manufacturing record and the shipping inspection record of the actual device found no anomaly.No similar complaint was received.Based on the investigation results, no anomaly was found in the manufacturing record and the shipping inspection record.Since the actual device could not be confirmed in this case, it was not possible to clarify the cause.Relevant instructions for use (ifu) reference: "make sure the recirculation circuit and the purge line are not clamped, then start pump at a low speed.After checking for leakage or any other problem, gradually increase flow above 0.5 l/min, but do not exceed 1.5 l/min.Vigorously recirculate the priming fluid through the entire circuit until all air bubbles are eliminated.After all air bubbles are eliminated, circulate at full flow for 10 min to check oxygenator and tubing for leakage or any other problem." "before initiating extracorporeal circulation, be sure to confirm that recirculation line and purge line are closed and sampling line is also closed with arterial side stopcock.Otherwise, opening arterial line will cause the blood to flow back into reservoir through sampling line because of the patient's blood pressure and the head height.".

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya-shi, shizuoka 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24210178
• Report Number: 9681834-2026-00012
• Device Sequence Number: 20188507
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: (01)04987350781758(17)271231(10)250122
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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*FX05RE
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 250122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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