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

Model Number 3CX*FX25REC

Device Problem Increase in Pressure (1491)

Patient Problem No Information (3190)

Event Date 07/06/2019

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, there was noticeable pressure drop to 400 mmhg as well as poor oxygenation performance after a repeated start of extracorporeal circulation.This resulted to an intraoperative system change.No other information about the nature of the issue was provided.

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: identification of evaluation codes 10, 3331, 213, 67.Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was inspected upon receipt.Visual inspection did not find any obvious anomaly that could lead to the poor gas transfer such as break in the appearance.The actual sample after having been rinsed and dried was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.Bovine blood was circulated in the oxygenator module and no anomalies were revealed and the obtained values met the factory specification.As the observed event was not able to be replicated, a definitive cause cannot be determined from the available information.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, and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on july 31, 2019.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: 8848583
• MDR Text Key: 159596069
• Report Number: 1124841-2019-00209
• 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: 10/17/2019

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 Expiration Date: 01/31/2022
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: XC18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/03/2019; 10/09/2019
• Supplement Dates FDA Received: 09/18/2019; 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR