MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RW30C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the fiber was broken.It is unknown if there was a delay in the procedure, whether the product was changed out, or if there was any effect on the patient or results of the surgery.
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.(b)(4).
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 january 03,2023.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 additional information).H3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information indicates that the product was changed out.
Additional 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: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was visually inspected with no anomalies noted such as breakage.It was then leak tested by installing into a circuit consisting of tubes, and saline solution was circulated with a flow rate of 5 l/min.No leakage was found.The blood channel was then filled with colored saline solution, the blood outside side was clamped, pressure of 2 kgf/cm2 was applied from the blood inlet side into the blood channel, and no leakage was found.The water channel was then filled with colored water, the water outlet was side clamped and pressure of 3 kgf/cm2 was applied form the water inlet side into the water channel.No leakage was found.The manufacturing and incoming inspection record of the actual sample was found to have no anomaly.Past complaint files were also reviewed with no similar report of the product involved product code / lot number.The evaluation of the returned sample was found to have no anomalies that would lead to leakage.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 3L 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: 16091209
• Report Number: 1124841-2023-00006
• Device Sequence Number: 6733550
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2023

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: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 2F02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 02/13/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/01/2023; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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