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

Model Number	CX*FX15E
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: ccp.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 cardiopulmonary bypass, the oxygenator experienced a sudden drop in pump flows; potential hpe situation.45 minutes post xclamp, flows suddenly dropped to about.8 c.I.There were no kinks in the a line or the cannula.Oxygenation, co2, and acts remained normal.Rewarming was attempted with repositioning of the xclamp with no change.Rpms were maxed and with very low flows.Femoral cannulation was attempted with no change.The flow probe was repositioned with no change.A new pump was brought in and normal flows were resumed; the procedure was completely successfully.The patient experienced low flows for 18 min with systolic pressures in the 30's.The patient had polycythemia vera which carries an increased risk of clotting on bypass even with proper act levels.The customer was suspicious of high-pressure excursion.The event resulted in delays of the surgical procedure.800 ml of blood loss was a result of the reported issue.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9.An oxygenator and a centrifugal pump (manufactured by tcvs) were returned.No damage or other abnormalities were observed at the time of receipt.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 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: 24520769
• Report Number: 9681834-2026-00041
• Device Sequence Number: 9655758
• Product Code: DTZ
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CX*FX15E
• Device Catalogue Number: N/A
• Device Lot Number: 250721
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 05/12/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/20/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male