MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2021

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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 Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the pre-membrane pressure was 700.As per user facility, the oxygenator was changed only when the cpb ended, after the procedure and after the protamine was administered.The prime was 895 ml of crystalloid + 100 ml of mannitol + 5000 units of heparin.The act prior to cpb and 5000 units of heparin on the priming was 452 seconds.Heparin was administered for 16 minutes.They were on bypass for 24 minutes when they saw the pressure increased gradually.The residual blood was returned to the patient before changing the oxygenator.14h29 : administration of 27 000 units of heparin iv.14h39 : act post administration of heparin = 452 seconds.14h45: cpb start (5000 un of heparin was delivered in the priming) pump pressure is 242 mmhg.14h48: cross-clamping (no problem at this moment, pre-membrane pressure is 248 mmhg).14h55: blood sample is taken for gazes and act measurement (pre membrane pressure is 288mmhg).15h00: the act of 14h55 is 430 (pre membrane pressure is 241mmhg).15h01: administration of 5000 un of heparin (pre membrane pressure is 218 mmhg) the act was not measured again because the act was above the baseline of 425 sec.15h09: at this time, the pre-membrane pressure started to rise, but the aortic pressure was equal as before.It was checked if there were any kinks in the tubing's.The pre-membrane was raised to fully perfuse the patient and changed the pressure reader.They continue to perform the cpb and change the oxygenator after the protamine administration.The pressure reader was changed one more time however, they still have a high pre membrane pressure (above 500-550 mmhg) but the aortic pressure was at the same level.Considering those facts, i decided to close my pre membrane pressure reader, because with the alarm open, they were not able to fully perfuse the patient.They decided to monitor the act more frequently and administer heparin two times after the problem started to appear.No consequences or impact to patient.The product was changed out.The surgery was completed successfully.

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 february 8, 2021.Upon further investigation of the reported event, the following information is new and/or changed: the actual sample was visually inspected and did not find any anomaly including breakage.After rinsing and drying, it was installed into a circuit consisting of tubes, and the pressure drop when circulating bovine blood (hct: 35%, temp: 37 degrees celsius) in it was measured.It was confirmed to meet the factory's specifications and no obstructions was found.Review of the manufacturing record and incoming inspection record of the actual product confirmed that there was no anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11294551
• MDR Text Key: 249314150
• Report Number: 1124841-2021-00015
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: YH20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 67