MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RE30C
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a build up of fibrin on the left side of the membrane.Per facility, they have confirmed through their lab that the build-up post filter was primarily platelets.No consequences or impact to patient.The product was changed out.The surgery was completed successfully.
Event or Problem Description
New information received indicating that the customer confirmed through their lab that the build-up post filter was primarily platelets.
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 december 30, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information & correction).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code11.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.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date and udi number).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation: #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not returned.The provided images at the time of the occurrence confirmed the event.Based on the information from the customer, they confirmed that through their lab, the post filter was primarily platelets.It was inferred that the white substance was the white blood clot generated by blood properties at the time of use.However, since it was not possible to investigate the actual product, it was also not possible to clarify the cause of the white substance and its causal relationship.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 3L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM 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: 13119030
• Report Number: 1124841-2021-00287
• Device Sequence Number: 17264616
• Product Code: DTZ
• UDI-Device Identifier: 00699753450448
• UDI-Public: (01)00699753450448
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151389
• 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,Followup
• Report Date (Section B): 02/18/2022

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: 07/31/2023
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: YK03
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 12/27/2021; 02/17/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/12/2022; 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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