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

Model Number	3CX*RX25RE
Medical Device Problem Code	Particulates (1451)
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
Terumo has received the device for evaluation; however, 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, a white flake floating in the reservoir was noticed.As per the user facility, they removed the venous reservoir outlet tubing and drained the particulate piece out into a specimen cup.The outlet tube was replaced and priming was finished.They were able to run the circuit with no issues.No known consequence or impact to patient.Product was not changed out.Procedure was completed successfully.
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 january 3, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) ; d9 (device availability - updated date returned to manufacturer) ; g3 (date received by manufacturer) ; g6 (indication that this is a follow-up report) ; h2 (follow-up due to correction, additional information & device evaluation) ; h3 (device evaluated by manufacturer); h4 (device manufacture date) ; h6 (identification of evaluation codes 10, 3331, 11, 202, 25).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 11 - testing of device from same lot/batch retained by manufacturer.Investigation findings: 202 - inappropriate material.Investigation conclusions: 25 - cause traced to manufacturing.The returned sample was visually inspected upon receipt.However, the reservoir was not returned, only the foreign material inside a specimen trap.It is confirmed that there was a white piece of foreign material in the specimen trap, when measure it was found to be out of specifications.A representative retention sample from the same lot was obtained and visually inspected.No foreign material was noted anywhere on the device.All capiox units are 100% visually inspected in process.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 16091171
• Report Number: 1124841-2023-00005
• Device Sequence Number: 15129816
• Product Code: DTZ
• UDI-Device Identifier: 00699753450103
• UDI-Public: (01)00699753450103
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 08/31/2025
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: 2L05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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 Sex: Unknown