MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX05 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, unknown.Date of birth: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number: unknown.Health professional: unknown.Occupation: unknown.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 involved product/lot number combination confirmed there were no anomalies in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.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 small bubbles were constantly appearing on the top of oxygenator during the cardiopulmonary bypass (cpb) procedure performed.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section d1.
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.Visual inspection of the actual sample found no anomaly such as a breakage.The actual sample after cleaned was filled with colored saline solution and pressurized at 2kgf/cm2 from the blood inlet side while the blood outlet was sealed.No leakage leading to air bubbles in the oxygenator was observed.The actual sample was incorporated into a circuit consisting of tubes and priming was performed with colored saline solution.No remaining air or no inflow of air was observed.Saline solution was circulated through the actual sample at 1.5l/min for one (1) hour.No air inflow was observed.After the circulation of 1 hour, another 1 hour was performed at 1.5l/min with air being blown at the maximum flow rate of 5 l/min.No air inflow was observed.According to the investigation results, no anomalies leading to the appearance of air bubbles inside the oxygenator were observed in the actual sample.As for the cause of this incident, it was considered that air flowed into the oxygenator due to some factors, or that air remained during priming.However, since no anomalies were observed in the actual sample, it was not possible to clarify the cause.Relevant instructions for use (ifu) reference: "ensure that the de-airing process is complete prior to initiating bypass.(c.Initiation of bypass)"."during recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.(warnings)"."do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.(warnings)"."pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.(warnings)"."the gas flow rate should not exceed 5l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.(warnings)"."to prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 0.5l/min.(warnings)" "recirculate the priming solution at a rate of 0.5 l/min or higher to facilitate air removal.( b.Priming procedure cautions)".

• Brand Name: CAPIOX RX05 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16087978
• Report Number: 9681834-2022-00265
• Device Sequence Number: 2045491
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: 04987350763471
• 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): 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): 01/03/2023

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 220401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 12/19/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/10/2023; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: 12 MO
• Patient Sex: Male