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

Model Number 3CX*FX15RE40C

Device Problem Increase in Pressure (1491)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2020

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 during cardiopulmonary bypass, there was a progressive increase in the pre oxygenation pressure.No known impact or consequence to patient.The product was not 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 june 23, 2020.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.

Event Description

New information received that post oxygenator value was 400mmhg.

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: 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 third 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.The sample was visually inspected and did not find any anomalies, such as break, in appearance.The actual sample was rinsed, dried and built into a circuit with tube.Bovine blood (hct 35% and temp 37 degrees) was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the factory's specification.No obstructions was confirmed.The actual sample was flushed with physiological saline solution.No clot that could lead an increase in the pressure was found inside the actual sample.Review of the manufacturing record and the incoming inspection record of the involved product/lot # combination confirmed there were no indication of anomalies in them.The investigation result verified that the actual sample after having been rinsed was the normal product presenting no problem.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
• MDR Report Key: 10184200
• MDR Text Key: 196086879
• Report Number: 1124841-2020-00145
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• 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,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: XH08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 60