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

Model Number 3CX*FX25RWC

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular a damaged cap on port of the oxygenator, and damaged oxygenator housing.It is unknown when this event occurred, whether there was a delay in the procedure, whether the product was changed out, whether the procedure was completed successfully, if there was any effect on the patient as a results of the surgery, and if there was any blood loss.Terumo continues to attempt to gain more information regarding this event from the user facility.Patient's year of birth: 1957.

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.H6: component code #1: 424 - cap.Component code #2: 839 - housing.Health effect - impact code: 4648 - insufficient information.Health effect - clinical code: 4580 - insufficient information.Medical device problem code: 1069 - break.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 june 5, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem - added new information); 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 2645, 4582, 10, 11, 3331, 3259, 4307).Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The returned sample was inspected upon receipt and confirmed to have a broken yellow cap on the venous inlet port and significant damage to the reservoir lid.A representative retention sample was visually inspected, no damage noted on the device.All capiox units are 100% visually inspected at several points in the production and packaging processes.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received that, this occurred during setup, no delay and no blood loss.No patient involvement.Product was changed out.Procedure completed successfully.

• 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: 17059371
• MDR Text Key: 316935670
• Report Number: 1124841-2023-00137
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 06/29/2023

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: 2D14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White