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

Model Number	CX*FX05RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: perfusionist.G4: pma/510(k): k130280.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 of the actual product.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.
Event or Problem Description
The user facility reported that leakage at the outlet of the oxygenator occurred during priming.The event occurred pre-treatment; therefore, no patient was involved.The procedure outcome was not reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Investigation of the actual sample: visual inspection of the actual sample found no anomaly such as a breakage was found.Leak test of the actual sample: the actual sample was installed into a circuit consisting of tubes, and the colored saline solution was circulated through the actual sample at a flow rate of 1.5 l/min.No leakage was found.The blood channel of actual sample was filled with colored saline solution, the blood outlet side was blocked, and a pressure of 2 kgf/cm2 was applied to the blood channel from the blood inlet side.No leakage was found.No anomaly was found in the manufacturing record and the shipping inspection record of the actual sample.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no leakage was found in the actual sample.The issues described could not be confirmed with the returned sample.In ashitaka factory, 100% leak test of this product is performed.Therefore, it was not possible to clarify the cause of occurrence.Relevant instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir." "band all connections in the circuit.".

• Brand Name: CAPIOX®FX
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20913318
• Report Number: 9681834-2024-00232
• Device Sequence Number: 12724294
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)260831(10)230911
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Expiration Date: 08/31/2026
• Device Model Number: CX*FX05RW
• Device Catalogue Number: N/A
• Device Lot Number: 230911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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