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

Model Number 3CX*FX25RWC

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

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 11.Component code: 4739 - gas exchanger.Health effect ¿ impact code: 2199 - no health consequences or impact.Health effect ¿ clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1491 - increase in pressure.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that there was a high-pressure excursion across the oxygenator.Additionally, the issue was discovered after 40 minutes of bypass.They mitigated/resolved the issue by injecting an initial dose of 200mg of nipride into the pre membrane isolator, with 5x 100mg nipride every 10 minutes until pressures return to normal.No known consequence or health impact to patient.Product was not changed out.Procedure was completed successfully.

Event Description

New information received that the event occurred during cardiopulmonary bypass.

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 may 5, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b3 (added date of event); b5 (added describe event or problem); d4 (additional device information - added exp date); e1 (added establishment name & address); g1 (corrected contact office- name, email address & telephone number); g3 (date received by manufacturer); g6 (indication that this is a follow-up report) ; h2 (follow-up due to additional information and correction) ; h4 (device manufacture date); h6 (identification of evaluation codes 4114, 3331, 3221, 4315).Type of investigation #1: 4114 - device not returned.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation.The manufacturing and incoming inspection record of the actual product was found to have no anomalies.Without the actual sample, the cause of the occurrence could not be clarified.A possible cause was inferred that blood-derived obstruction occurred and the pressure was increased.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: g3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 213, 67).Type of investigation: 10 - testing of actual/suspected device.Investigation findings: 213 - no device problem found.Investigation conclusions: 67- no problem detected.The returned sample was visually inspected upon receipt with no damage or anomalies leading to high pressure excursion.It was then tested for pressure drop with bovine blood.It was confirmed that a maximum blood flow rate of 7 l/min could be obtained, and the pressure drop was able to meet the factory's specifications with no obstruction found.Saline solution was flowed in the blood channel.As a result, no formation of blood clot was confirmed.There was no anomalies found during evaluation, and it was not possible to clarify the cause of the complaint from the investigation result.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

High pressure excursion across oxygenator.

Event Description

High pressure excursion across oxygenator.

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: d9 (device availability - added date returned to manufacturer) g3 (date received by manufacturer) g6 (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.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16875938
• MDR Text Key: 314665453
• Report Number: 1124841-2023-00104
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2P12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1