MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number	3CX*RX25RE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, bubbles were seen after oxygenator was connected.As the oxygenator was connected, the passage of bubbles were evident.The oxygenator was connected to the recirculation lines of the extracorporeal circuit, it was in the process of purging the circuit so it was not yet connected to the arterial cannula for extracorporeal circulation.The bubbles were evident at the exit of the oxygenator at the arterial port of the capiox rx 25, reaching the lines of recirculation, manifold and arterial filter af125.The priming assist line was occluded.The arterial roller pump was used, when performing maneuvers to reduce blood flow and increase it the bubbles were produced.The flow of the arterial roller was stopped to perform the evaluation of possible external causes of air embolism generation and for the process of replacing oxygenation membrane with a new one.The arterial pump was operating with flow almost 2.5lt/min, the arterial pump was stopped for the oxygenator change out.All luer connections, tubing connections, stopcocks in the circuit were checked to ensure that there was no air entrainment.No patient involvement.There was a delay during the process of arming and baiting the extracorporeal circuit.The product was changed out.Procedure was completed successfully.
Event or Problem Description
As per clinical specialist the customer provided video which shows air bubble in the fiber bundle and air in the line attached to the 1/4 inch port on the blood outlet port of the oxygenator.Air was going out of the oxygenator blood outlet port into the 1/4 inch line and as the air in the 1/4 line oscillated some air was migrating into the 3/8 inch arterial line.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem) d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 213, 67) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 67 - no problem detected the actual sample was visually inspected upon receipt with no breakage or similar anomalies that could lead to the entrained air.After having been rinsed, it was then built into a circuit with tube, filled with normal saline colored for better visibility, and then circulated at 7l/min, which is the maximum blood flow rate specified for the product.No entrained air was observed.The blood outlet side was occluded and the air pressure was applied at 2kgf/cm2 for six hours and no leak was observed.The evaluation result verified that the actual sample had no anomalies that could lead to the generation of air bubbles.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on february 02, 2021.  upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11268123
• Report Number: 1124841-2021-00013
• Device Sequence Number: 1283970
• Product Code: DTZ
• UDI-Device Identifier: 00699753450103
• UDI-Public: (01)00699753450103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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: 01/31/2023
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: YC17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/03/2021; 03/05/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/26/2021; 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1