MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RE OX W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RE

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

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 procedure there was an issue with the oxygenator.There was a clear spot at top the oxygenator over the center of the fiber bundle, outside of the filter material.No consequences or impact to patient.Product was not changed out.Procedure 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 march 8, 2019.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).The sample was received on march 19, 2019 and at that time, it was determined that the device reported was not a tcvs manufactured product.Therefore, there will not be any investigation information completed or submitted by tcvs.The investigation will be completed by the manufacturer.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RE OX 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: 8405713
• MDR Text Key: 138570494
• Report Number: 1124841-2019-00063
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450462
• UDI-Public: (01)00699753450462
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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 Model Number: 3CX*FX25RE
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1