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

Model Number	3CX*FX15RW40C
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they have noticed a black mark particle in the plastic of the reservoir.No patient involvement.The product was changed out.The surgery was completed successfully.
Additional 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.Component code: 934 - reservoir.Health effect - impact code: 2645 - no patient involvement health effect - clinical code: 4582 - no clinical signs, symptoms or conditions medical device problem code: 2944 - device contamination with chemical or other material investigation findings: 3233 - results pending completion of investigation conclusions: 11 - conclusion not yet available.
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 february 8, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration 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 10, 11, 3331, 213, 67).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 #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The affected samples were inspected upon receipt to confirm a black mark in each unit in the reservoir that were embedded within the plastic.The marks were measured and was found to be within specification.A representative retention sample was inspected to show no anomalies with the device, including no foreign materials.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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 16323291
• Report Number: 1124841-2023-00041
• Device Sequence Number: 8583738
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/08/2023

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: 07/31/2023
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: YK10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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