MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CXFX25RWC

Device Problem Device Alarm System (1012)

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

Event Date 08/03/2020

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.For this reason, terumo references evaluation conclusion code.(b)(4).

Event Description

The user facility reported to terumo cardiovascular during cardiopulmonary bypass, the bubble alarm was activated even if they couldn¿t see anything obvious.Per user facility, they were on bypass for 10-15 minutes when the bubble alarm was activated.The reservoir was full at time of activation.They couldn¿t see anything obvious, clamped arterial line, recirculated, bubble alarm did not reactivate and therefore went back on bypass.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 august 24, 2020.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem); d4 (additional device information - added expiration date); d11 (concomitant medical products - added medical product); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned so a thorough investigation could not be performed and a definitive root cause could not be identified.A representative retention sample was obtained and inspected for visual anomalies with no anomalies noted.The sample was then built into a water circuit with the arterial sampling line attached to the sampling manifold and the return from the manifold attached to the venous pigtail.During the circulation the sample was observed for leakage and air bubbles.No leakage was observed.No air was observed in the system following initial priming/de-airing of the system.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Per clinical specialist, the bubble detector setting was 5mm and the micro bubble function was not enabled.

• Brand Name: STERILE FX25RWC 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: 10446509
• MDR Text Key: 206115737
• Report Number: 1124841-2020-00198
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• 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
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 3CXFX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: YC17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SORIN S5.