MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: others.The actual sample was not returned to the ashitaka factory.The provided video was confirmed.It was found that the tube was connected to the gas outlet side of oxygenator.There were no pump records obtained.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation result, no anomaly was found in the manufacturing record or the shipping inspection record.Since the actual sample could not be confirmed, and detailed information and pump records were not obtained, it was not possible to clarify the cause of oxygenation failure.Regarding the additional information that "they tested the gas flow by connecting the gas out port with a tube", the structure related to the gas flow channel of our capiox rx was described.The gas outlet side is designed with the housing adhered in the center and has a gap on the outer circumference.This may involve connecting a tube to the gas out port to collect gas from the gas outlet when blowing oxygen gas mixed with anesthesia.Currently, since it is necessary to suck more gas than insufflation gas, the gas outlet side is open.On the gas inlet side, the outer circumference of housing is adhered so that the inflowing gas does not leak.Relevant ifu reference: "start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.(c.Intiation of bypass warnings)" "measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.(d.During perfusion, 2)" 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 no oxygenation was found after the cpb ran, po2 50-60 mmhg.After the circuit was checked, no gas flow from the gas outlet was found, even if gas flow setting was 8.0l/min.The event occurred intra-operative.There was no patient injury/medical or surgical intervention.The procedure outcome was not reported.The final patient impact was not harmed.Additional information was received on (b)(6) 2022: the product was not replaced.The procedure was switched to off-pump surgery.The provided video was checked, and it was found that a tube was inserted into the gas out of the oxygenator; however, the tube connection on the in port side could not be found.The gas line was installed correct.The air-in port was connected with a tube from the gas source.The gas flow from the gas source was normal.The gas flow was tested by connecting the gas out port with a tube and putting it into water.It was found that there was no gas flow from the out port.

• Brand Name: CAPIOX RX25 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: 15531534
• Report Number: 9681834-2022-00198
• Device Sequence Number: 17446329
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 210823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: Female