MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX25RWC
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular, after cardiopulmonary bypass, the arterial / venous temperature were 4 degrees below.Per facility, perfusionist was rewarming the arterial /ven temps were 4 degrees below water bath and bladder temp probe.They have done an equipment check and feel the temp probes and or oxy temp wells may have an issue.Cdi550 corresponded with oxy art/ven.They changed out probes with new ones to resolve the problem.No patient impact or involvement.The product was not changed out.The surgery was completed successfully.
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).
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 august 31, 2022.Upon further investigation of the reported event, the following information is new and/or changed: correction) h6 (identification of evaluation codes 11, 3331, 4114, 213, 67) type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #2: 3331 - analysis of production records type of investigation #3: 4114 - device not returned investigation finding: 213 - no device problem found investigation conclusions: 67 - no problem detected the affected sample was not returned for evaluation; however, the additional complaint details it is stated that the temperature probe was changed out for a new one and the procedure was completed successfully.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
The event occurred during cardiopulmonary bypass.

• Brand Name: STERILE FX25RWC W/ RES
• 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: 15331414
• Report Number: 1124841-2022-00148
• Device Sequence Number: 17464916
• Product Code: DTZ
• UDI-Device Identifier: 00699753450844
• UDI-Public: (01)00699753450844
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151791
• 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): 11/18/2022

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: 04/30/2025
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2F23
• Was Device Available for Evaluation?: No
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2025
• 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