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

Model Number	CX*RX25RW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: requested, unknown.E3: occupation: requested, unknown.The actual device was not returned for evaluation; however, a photograph of the actual device was returned for evaluation.The provided image of the actual sample showed that the female luer port of the blue cock in the sampling system had been broken at its base.However, it was not possible to confirm the condition of the broken surface from the image.The manufacturing and shipping inspection records for the actual sample showed no anomalies.Review of past complaint files for the specified product code/lot number revealed no other similar reports.Cause of occurrence/conclusion based on the investigation results; no anomalies were found in the manufacturing records.Since the condition of the damaged surface of the actual sample could not be confirmed, it was not possible to clarify the cause of occurrence.Relevant instructions for use (ifu) reference: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.If the product is dropped during set-up, do not use it.Replace it with another device.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved capiox device cock system was broken.The event occurred prior to treatment, therefore there was no patient involvement.The final patient impact was unharmed.

• Brand Name: CAPIOX®RX
• 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 ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 20379385
• Report Number: 9681834-2024-00173
• Device Sequence Number: 8097147
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)261130(10)231220
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2024

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*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: 231220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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