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

Model Number 3CX*FX15RE40C

Device Problem Gas Output Problem (1266)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/23/2021

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was an increase in the inlet pressures of the oxygenating chamber that is noted with a decrease in gas exchange.As per the subsidiary, the patient was with ischemic heart disease undergoing coronary artery bypass surgery with urgency.After 30 minutes from the aortic clamping with an act greater than 480, an increase in the inlet pressures of the oxygenating chamber was noted with a decrease in gas exchange; after 6 minutes the inlet pressure reaches values exceeding 600 mmhg at the inlet and bringing ventilation at 100% oxygen with 9.5 liters /m of air at a blood flow of 5 liters /minutes.There was a po2 of 69 mmhg and pco2 within the norm but visually one began to noticed fibrin filings adhered around the polycarbonate of the oxygenating chamber especially towards the part of the connections for the thermocirculator.At this point the user decides to bring the blood temperature to 28 °c, the inlet pressures of the oxygenating chamber reach values of around 800 mmhg, therefore it is decided to proceed with the immediate replacement of the device by installing a new oxygenator of the same type.The patient was connected to extra corporeal circulation.Extra-body circulation time was 136 minutes procedure duration h.5.30.Additionally, the patient was treated as intended, and had a normal post operative course without complications.The product was changed out.There was a blood loss of 150 ml.There was a 5 minute delay for replacing the oxygenator.Procedure was completed successfully.

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).

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 15, 2022.  upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer), g3 (date received by manufacturer), g6 (indication that this is a follow-up report), h2 (follow-up due to additional information), h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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: 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 findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was received and was visually inspected with no anomaly including a breakage.After the rinsing the sample, it was installed into a circuit consisting of tubes, and a pressure drop when circulating bovine blood at a flow rate of 5l/min was measured and it was confirmed to meet the factory's specification and no obstruction was found.The blood channel was then flowed with saline solution and no blood clot that led to the increasing of pressure was formed.Based on the investigation results, there was no anomalies found in the actual sample after rinsing.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
• 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: 13262466
• MDR Text Key: 289064795
• Report Number: 1124841-2022-00005
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: ZH19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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