MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Use of Device Problem (1670)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was an oxygenator failure.As per the user facility, the oxygenator failed after 5 minutes - initiated bypass.The patient's sats dropped and blood in the arterial line noted as dark.Abg (arterial blood gas) was done.Blender and vaporizer were checked, and they were working as normal.They switched over to oxygen cylinder to confirm oxygenator failure and blood on the arterial line remained dark red.By that time, gas had come back and po2 was noted at 40; a confirmation of the oxygen failure.The changed out occurred with a new oxygenator during the procedure, and the arterial line changed to bright red, and the patient's sats went up to100 again and no negative effect on the patient.No consequence or impact to patient.Product was changed out.Procedure was completed successfully.

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

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.H6 (identification of evaluation codes 4641).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 an intervention, as the product was changed out.

Event Description

Oxygenator failure.

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 october 6, 2023.Upon further investigation of the reported event, the following information is new and/or changed: 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).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 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 actual sample was not returned for evaluation; therefore, a thorough investigation could not be performed.The manufacturing and incoming inspection records, of the actual product was found to have no anomaly in the estimated lots.However, without the actual sample, a definitive root cause could not be determined.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 correction additional information and device evaluation); h6 (identification of evaluation codes 10, 213, 67).The returned sample was visually inspected upon receipt with no anomaly such as breakage.It was then rinsed and dried, with the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure.It was confirmed to meet the factory's specifications with no anomalies found.The color of both venous blood and arterial blood were confirmed during gas transfer performance.It was found that the color of arterial blood was bright red compared to the color if venous blood.Review of the manufacturing record and the incoming inspection record of the involved product code found no anomaly in them.Based on the evaluation, no anomaly was found in the performance test of the actual sample; therefore, it was not possible to clarify the cause of the event.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: h3 (device evaluation anticipated by manufacturer - 81 - evaluation is in progress, but not yet concluded).A fourth 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.

Event Description

Oxygenator failure.

• Brand Name: STERILE FX15RWC 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: 17890164
• MDR Text Key: 325466465
• Report Number: 1124841-2023-00240
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K151389
• 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,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 2F30
• 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: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2022
• 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
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American