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

Model Number	3CX*RX25RW
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2021
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, air bubbles were noted coming out of the arterial and cardioplegia outlet of the oxygenator.No health consequences or impact.Delay of about 30 minutes.Product was changed out.Procedure was completed successfully.
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: 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, 4210, 4307) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 4210 - leakage/seal investigation conclusions: 4307 - cause traced to component failure the actual sample was visually inspected upon receipt and a scratch was found on the bottom side of the blood outlet port.The tubes connected to the outlet port has been removed; therefore, it was unknown when the scratch was generated.No other anomaly was found in its appearance of other sections.The actual sample was installed into a circuit consisting of tubes, it was then filled with a colored saline.A leak test was performed by applying pressure of 2kgf/cm2 from the blood inlet port with the tube on the blood outlet port clamped.A small amount of leak was observed from the tube connection of the blood outlet port, but no leak was observed from other sections.It was likely the leak near the blood outlet port was caused by the scratch found.With the small amount of leak, a positive pressure was applied to the blood outlet port during circulation, and it was inferred that there was no casual relationship with the reported air bubbles.As a possible cause, it was likely that during the circulation the inside of the oxygenator became negative pressure, due to some factor and air was drawn in through the fiber.The inside of the oxygenator may become negative pressure in these following cases, when the flow rate of cardioplegia line connected to the bcp port exceeds the flow rate of the main circuit, or when the roller pump is suddenly stopped during circulation, the liquid is flowing out due to inertia; this temporarily creates negative pressure inside the oxygenator.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 april 1, 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 WEST
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11605540
• Report Number: 1124841-2021-00073
• Device Sequence Number: 17030232
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/25/2021

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: 07/31/2022
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: XK12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 06/24/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/10/2021; 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1