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

Model Number 3CX*FX25REC

Device Problem Use of Device Problem (1670)

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

Event Date 08/11/2023

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.H6: 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: 1670 - use of device problem investigation findings: 3233 - results pending completion of investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenation performance became more and more inadequate; with few minutes delay during the oxygenator swap at the hlm.*no health consequence or impact to patient *product was 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 september 12, 2023.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

The oxygenation performance became more and more inadequate.

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: d4 (additional device information - added expiration date) 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) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 213, 67) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 67 - no problem detected visual inspection of the actual sample upon receipt found no anomalies.The actual sample, after having been rinsed and dried, was tested for its oxygen transfer performance and carbon dioxide removal performance.As a result, no anomalies were revealed in the gas transfer performance with the obtained values, meeting the factory¿s specifications.The pump record was checked; however, the information such as po2 was unknown, and it was unable to determine the cause of the gas transfer failure.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

The oxygenation performance became more and more inadequate.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17728591
• MDR Text Key: 323168617
• Report Number: 1124841-2023-00224
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 2L26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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