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

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/27/2023

Event Type  Death  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was an oxygenator failure.As per the user facility, to mitigate the issue they put an fx15 in recirculating line.The patient expired.The product was changed out.The surgery was completed successfully.There was 11,587 mls of blood loss.

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: 1802- death.Health effect ¿ clinical code: 1888 - hemorrhage/bleeding.Medical device problem code: 1670 - use of device problem.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

Event Description

New information received that the product was not changed out, and there was no blood loss.

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: b5 (updated describe event or problem).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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 24, 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 4114, 3331, 3221, 4315).Type of investigation #1: 4114 ¿ device not returned.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The sample was not returned for evaluation; therefore, a thorough investigation could be performed, and a definitive root cause could not be determined.Review of the manufacturing record and the incoming inspection record of the involved product regarding the estimated lots was found to have no anomaly in them.Without the actual sample it was unable to verify the information and the cause of the occurrence could not be determined.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: 17997082
• MDR Text Key: 326411235
• Report Number: 1124841-2023-00248
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 3K14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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
• Patient Outcome(s): Death