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

Model Number	CX*FX25RW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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.E1: initial reporter name: unknown.E1: establishment name: (b)(6).E1: phone number: unknown.E3: occupation: unknown.G4: 510(k) no.: k130520.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted, however a video was obtained.Confirmation of the provided video it was observed that the tube of the sampling line was fractured.The manufacturing record and the shipping inspection record of the actual device no anomaly was found.Past complaint file of the involved product code/lot number no other similar report was found.Based on the investigation results, no anomaly was found in the manufacturing records.The cause of this case was thought to be some kind of impact load applied to the tube of the sampling line from shipment to the time of use.From our experience, it was thought possible that it became fractured when an impact load is applied while the tube is cooled.As a result of confirming the temperature in urumqi from shipment to the time of use, it was recognized that there was a period of low temperature.However, since the actual device could not be confirmed, it was not possible to clarify the cause of the occurrence.Relevent ifu reference: if the product is dropped during set-up, do not use it.Replace with another device.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: the sampling tube broke at the connection to the blood inlet port of the reservoir.The procedure outcome was not reported.There was no harm to the patient reported.

• 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: 24480161
• Report Number: 9681834-2026-00032
• Device Sequence Number: 16007688
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)280831(10)250916
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2026

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: 250916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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