MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RW40C
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional 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: 525 - tube.Health effect ¿ impact code #1: 2199 - no health consequences or impact.Health effect ¿ impact code #2: 4604 - delay to treatment/ therapy.Health effect ¿ clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 4062 - air/gas in device.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a small bubbles observed in the arterial line on commencing bypass.As per the subsidiary, these bubbles were not observed during priming or prior to bypass.They came back off bypass as aortic clamp had not been applied and recirculated via av loop.Re-commenced bypass and no further bubbles observed.Gas exchange on bypass was as expected.Surgery was completed with no further issues.The product was not changed out; as they made an a-v loop and recirculated for about 10 minutes.No known consequence or impact to patient.There was a 30-minute delay in the beginning of the surgical procedure.Procedure was completed successfully.
Event or Problem Description
The arterial line has small bubbles.
Additional 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 21, 2023.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11- testing of device from same lot/ batch retained by manufacturer type of investigation #2: 3331- analysis of production records.Type of investigation #3: 4114- device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315- cause not established.The sample was not returned for evaluation; therefore, a thorough investigation could not be performed.However, in the additional complaint details it is stated that recirculation was conducted via av loop and bypass was re-commenced and no further bubbles were observed.A representative retention sample was obtained and set up in a circuit.The sample was circulated with a saline solution and no bubbles were noted.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 FX15RWC W/ 4L RES
• Common Device Name: 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: 16582596
• Report Number: 1124841-2023-00076
• Device Sequence Number: 1635491
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K151791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: 2L19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown