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

Model Number	CX*RX25RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the capiox device involved had leakage.The user started priming as usual, and a leak at the water outlet was found.The user changed to a new oxygenator.The patient was reported to be safe.The procedure outcome was not reported.The final patient impact was not harmed.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: others.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.Visual inspection of the actual sample found that the water port outlet of actual oxygenator was deformed from the outside to the inside.No anomaly such as damage was found in other sections.Leak test of the actual sample found that after connecting the tube to the water port on the actual sample, colored water was circulated.No leakage was found.After connecting the coupler to the water port on the actual sample, similarly colored water was circulated.No leakage was found.The water channel of actual sample was filled with colored water, the water outlet side was clamped, and pressure of 3 kgf/cm2 was applied from the water inlet side into the water channel.No leakage was found.The blood channel of actual sample was filled with colored saline solution, the blood outlet side was clamped, and pressure of 2 kgf/cm2 was applied from the blood inlet side into the blood channel.No leakage was found.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, as a possible cause of occurrence, it was likely that deformation of the water port created a leakage path.However, since the leakage could not be simulated in the leak test, it was not possible to clarify the cause of this case.Relevant instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx25 oxygenator and reservoir.(b.Priming procedure warnings)" "if the product is dropped during set-up, do not use it.Replace with another device.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide a correction to section d4: udi.The udi was updated to match the correct format.Due to internal review, a correction was made to section d3.

• Brand Name: CAPIOX®RX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 18038721
• Report Number: 9681834-2023-00210
• Device Sequence Number: 7429167
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)260630(10)230704
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2023

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
• Device Expiration Date: 06/30/2026
• Device Model Number: CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: 230704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 08/08/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/17/2023; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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