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

Model Number 3CX*FX25REC

Device Problems Pumping Stopped (1503); Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  malfunction  

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).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the pump stopped with the thermocirculator(heater cooler device)running.Per subsidiary "during the occlusion phase of the master with the pump stopped with the thermocirculator running, the customer noticed that the level of the prime in the arterial line oscillated as if there was a boost pressure on the artery.No patient involvement.There was 45 minutes delay in the procedure.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 november 2, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability added date returned to manufacturer).G4 (date received by manufacturer).G7 (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 925, 2645, 4582, 1503, 10, 11, 114, 4315).Component code: 925 - pump.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1503 - pumping stopped.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Investigation findings: 114 - operational problem identified.Investigation conclusions: 4315 - cause not established.A visual inspection of the actual sample did not find any anomaly including a breakage.The actual sample was installed into a circuit consisting of tubes, clamped by a roller pump that stopped the blood inlet side of the oxygenator, and water was circulated to the water channel with the saline solution filled halfway through the line connecting to the blood outlet port.No fluctuation in the liquid level were observed.After investigation result, by changing the clamp state of the tube connected to the water port, the circulation pressure of the water channel was changed.It was confirmed that the fluctuation of the liquid level was reproduced.In addition, it was confirmed that the same fluctuation of the liquid level was reproduced in the factory-retained oxygenator.After connecting the factory-retained tube to the actual sample, the water channel was filled with water (colored to improve visibility), the tube connected to the water outlet port was clamped with forceps and pressure of 3 kgf / crn 2 was applied from the water inlet side for 6 hours.No leakage was observed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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
• MDR Report Key: 10771924
• MDR Text Key: 214170219
• Report Number: 1124841-2020-00251
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: YC17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1