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

Model Number	CX*FX25RW
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A5: ethnicity: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: establishment name: the third people's hospital of xinjiang uygur autonomous region.E1: phone number: unknown.E1: initial reporter name: unknown.G4: 510(k) no.: k130520.The actual device was not returned.Confirmation of the provided image: a tear was found in the packaging located on the back of the oxygenator.Manufacturing record and the shipping inspection record of the actual device found no anomaly.No similar complaint was received regarding the involved product code and lot.Based on the investigation results, no anomaly was found in the manufacturing records.As one of the possibilities, it was considered that excessive load was applied to the product while it was in the unit box, causing it to tear at the point where it was in contact with the sterilization bag.However, it was not possible to clarify when the load was applied or the cause of the occurrence.The instructions for use (ifu) (capiox fx25) indicates as follows: "do not use if the package or device is damaged (e.G., cracked) or any of the port caps are off." 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 reported information.There is a hole on the outer sterile plastic bag.The event occurred pre-treatment; therefore, no patient was involved or harmed.

• 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: 24003384
• Report Number: 9681834-2025-00244
• Device Sequence Number: 13308161
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)280531(10)250613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 250613
• 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: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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