MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX15REC W/3L RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX15RE30CA

Device Problem Use of Device Problem (1670)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed.*no consequence or health impact to patient.*product was changed out.*procedure was completed successfully.

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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.H3: 81 - evaluation is in progress, but not yet concluded.

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 january 10, 2024.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem d4 (additional device information - added exp 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) the affected sample was visually inspected upon receipt, with no anomaly such as breakage.After it was rinsed and dried, the unit was tested for oxygen transfer and carbon dioxide removal performance in accordance with the product inspection protocol.There was no anomaly found and the unit met the factory's specification.Therefore, the cause of the occurrence could not be clarified.The manufacturing and incoming inspection record of the actual sample was found to have no anomalies.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information indicates that the event is considered as an intervention to prevent impairment or damaged, as the product was changed out.

• Brand Name: NS FX15REC W/3L 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: 18489859
• MDR Text Key: 332990797
• Report Number: 1124841-2024-00006
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3ZZ*FX15RE30CA
• Device Catalogue Number: N/A
• Device Lot Number: 3H17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• 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