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

Model Number	CX*RX05RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported leakage occurred.During priming, the perfusionist found liquid was coming out of the gas outlet.The procedure outcome was not reported.The event occurred pre-treatment.There was no patient involved/harmed.
Additional Manufacturer Narrative
E3: occupation: technologist visual inspection of the actual sample upon receipt: flaws were found on the blood inlet port and the blood outlet port of the oxygenator.No anomaly such as a breakage was found in other sections.Leakage test of the actual sample: the actual sample was incorporated into a circuit consisting of tubes, and colored saline was circulated through it.As a result, no leakage from the blood channel to the gas channel was observed.Furthermore, when a bending load was applied to the tube connected to the blood inlet port of the oxygenator, it was found that the flaw became a leakage route, resulting in leakage.The tubes connected to the blood inlet port and the blood outlet port were fixed with cable ties, the blood outlet side was blocked, and the blood channel was pressurized at 2 kgf/cm2 from the blood inlet side.As a result, no leakage was confirmed.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No similar complaints have been filed.Based on the investigation results, no leakage was observed from the blood channel to the gas channel during the leakage test of the actual sample.However, leakage was observed at the connection between the tube and the port.It was thought that the flaw on the blood inlet port became a route for the leakage, but the exact causal link between this flaw and the reported leakage could not be determined.Note that each port undergoes a 100% visual inspection before a port cap is attached.This suggests that the flaws occurred after this inspection process.However, based on the condition of the actual sample, it was not possible to determine exactly when these flaws occurred.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." "do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx05 oxygenator and reservoir." 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).

• Brand Name: CAPIOX RX OXYGENATOR
• 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: 20662081
• Report Number: 9681834-2024-00202
• Device Sequence Number: 7285976
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: (01)04987350763471(17)270228(10)240312
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022115
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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 Model Number: CX*RX05RW
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 240312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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 Age: 12 MO
• Patient Sex: Male
• Patient Weight: 3 KG