MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was thrombus formation in the hardshell reservoir.Per facility, during bypass the perfusionist noticed thrombin forming in the hardshell reservoir.She then changed the reservoir out, not the oxy, and put a new hardshell reservoir in and the cases was finished with no other issues.Procedure: septal defect procedure - asd, tricuspid valve position - repair , there was a minute delay in the procedure, there was approximately 400 ml of blood loss, the product was changed out, the surgery was completed successfully, the patient is fine after the procedure.

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 september 12, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10,3331,213 ,67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was inspected upon receipt with some clotting noted within the reservoir.It was set up for cr and vr defoaming testing.The cr defoaming test was set up and blood was flowed at 5 lpm with air introduced into the suction ports at approximately 100ml/min for one hour.The unit was observed for foaming at 15-minute intervals for 1 hour.There was no foaming observed.Next the vr defoaming test was set up and blood was flowed at 8 lpm with air introduced into the venous inlet at approximately 100ml/min for one hour.The unit was observed for foaming after the first 5 minutes and 60 minutes, which is the end of test.There was no foaming or clotting observed.The unit was found to function as intended; therefore, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information as per the clinical specialist that, this complaint involved the reservoir of a fx25 oxygenator that had thrombin form on it approximately one hour into cardiopulmonary bypass.A pump record was provided that revealed adequate act values during the pump run and additional administrations of heparin.A hepcon value was taken prebypass that was adequate for bypass; however no other hepcon values were taken during bypass.From the information provided from the clinician, it appears that the patient either had some heparin resistance or something else going on that affected the ability to adequately anticoagulate the patient¿s blood.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: 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: 15402884
• MDR Text Key: 299701476
• Report Number: 1124841-2022-00151
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: ZN29R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 104 KG