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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that there was no abnormality in appearance of the oxygenator, the perfusionist built a circuit with it and primed as normal.Before the cpb circuit connected to patient, the perfusionist started circulation in circuit, the priming solution in reservoir disappeared, then re-add 500ml priming solution, start pump again, priming solution disappeared again.So the perfusionist judges that it is a oxygenator quality problems.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: udi no: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: address: requested, not provided.E1: phone number: requested, not provided.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and shipping inspection record of the actual sample: no anomaly was found.Review of the past complaint file of the involved product code/lot#:.No other similar report was found.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).
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.Inspection of the actual sample: 1.1.Visual inspection of the actual sample - no anomaly such as a breakage was found.1.2.Leakage test of the actual sample - the actual sample was built into a circuit of tubes, and physiological saline solution was circulated at a flow rate of 7 l/min and the back pressure of 200mmhg.No leakage was observed.- the liquid level of the reservoir was adjusted to 500 ml, and then the actual sample was allowed to stand for at least 6 hours.As a result, no drop in the liquid level was observed.- the blood channel was filled with colored saline solution, the blood-outlet side was blocked, and then the blood channel was pressurized at 2 kgf/cm2 from the blood-inlet side.No leakage was observed.- the water channel was filled with colored water, the water-outlet side was blocked, and then the water channel was pressurized at 3 kgf/cm2 from the water-inlet side.No leakage was observed.Cause of occurrence/conclusion the investigation result showed no anomaly that could lead to the leakage in the actual sample.As for the cause of the reported event, since no leakage was reproduced with the actual sample during the investigation, it was not possible to clarify the cause that the priming solution in the reservoir disappeared.Relevant ifu reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx25 oxygenator and reservoir.(b.Priming procedure warnings)" 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.2 to correct section d3.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya 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: 17213807
• Report Number: 9681834-2023-00121
• Device Sequence Number: 12308364
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 221103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 12/15/2024
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/18/2023; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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: 68 YR
• Patient Sex: Male