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

Model Number 3CX*FX25RWC

Device Problem Leak/Splash (1354)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a blood leakage at the outlet of the oxygenator; on the blood cardioplegia line.It is unknown if there was a delay in the procedure, and whether this was a leak direct from the oxygenator or a connection to the oxygenator.Product was not changed out.There was a blood loss of 50 ml.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: 1354 - leak/splash.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on march 14, 2023.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 a thorough investigation.A picture was provided; however, the exact location of the leak was not able to be confirmed.It is also noted that this is a customer made connection and there is not a tie band securing the arterial outlet tubing.Without a returned device, 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.

• 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 16537255
• MDR Text Key: 311236024
• Report Number: 1124841-2023-00066
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2E11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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