MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RE40C
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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 was reported to terumo cardiovascular that during cardiopulmonary bypass, an unexpected drop in po2 value when cryoprecipitate was given.As per the user facility, the patient was put in cardiopulmonary bypass at 10:06 a, with no issues.The first blood gas on istat showed a po2 of 506mmhg (fio2 = 100%) at 10:16am - this was used to calibrate the cdi550 and po2s were then measured real time for the duration of the cbp period.Po2s remained above 500mmhg until 12.45pm.Although there was an unexpected drop in po2 for the corresponding fio2, the patient was adequately oxygenated the entire time.When we weaned the po2 was around 140mmhg.The product did not need to be changed out; the lowest po2 reached was still in a safe range.*no known impact or consequence of the patient *the product was not changed out *the surgery was completed successfully.
Event or Problem Description
Per the clinical specialist, the customer shared some parts of the pump record.The patient was placed on cpb at 10:06am with no issues and an istat blood gas revealed a po2 of 506mmhg at fio2 of 100% at that time.This was used to calibrate the cdi 550 system to provide the following po2s.The po2s decreased marginally in the 400s mmhg range over the next few hours of bypass.At 1:45pm, the po2 was 442 mmhg.The act at that time was 581 seconds.Heparin in the amount of 10,000 iu was given at that time.Then at 1:57pm, an unknown amount of cryoprecipitate was given.The po2s steadily dropped from this point forward, from 297mmhg at 2:05pm down to 140mmhg at 2:43pm.The venous saturation dropped from 76% to 72% at those times.The act at 2:23pm was 841 seconds and at 2:43pm was 741 seconds.
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 june 16, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem); d4 (additional device information - added expiration date); 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 finding: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not available due to hepatitis b infection.A definitive root cause is unable to be determined; however, it is most likely that the cryoprecipitate that was given caused the poor gas exchange performance.Cryoprecipitate is derived from fresh frozen plasma or ffp.Ffp is blood plasma that is removed from whole blood and cooled to 18 degrees c within 8 hours of collection.Cryoprecipitate is made by thawing ffp at 1-6 degrees c and then centrifuging and collecting the cryoprecipitate.Both ffp and cryoprecipitate have collecting factors and fibrinogen, which promote clotting.Cryoprecipitate has a concentrated amount of fibrinogen and factor 7.It is a known contra-indication within perfusion management not to give cryoprecipitate during bypass as a result of the concentrated amount of fibrinogen and clotting factors in the component and its effect of increasing the gas exchange barrier leading to suboptimal gas exchange performance in the oxygenator bundle.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 4L 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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17145822
• Report Number: 1124841-2023-00146
• Device Sequence Number: 12198667
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 07/31/2025
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: 2K29
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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