MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RE30C
Medical Device Problem Codes	Leak/Splash (1354); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2020
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was creating a froth and subsequent gases was demonstrating poor oxygenation.The case was an lvad (left ventricular assist device) insertion, they were able to come off cpb but the aortic root was tore so they had to go back on cpb.The oxygenator was not recirculated while off cpb.Deep nypothermic circulatory arrest was completed when they returned to cpb in order to repair the torn aorta.The patient were not able to successfully come off cpb on lvad alone, rvad (right ventricular assist) device was inserted as well.The plasma leakage and deterioration of blood gases occurred when returning to cpb the last time.The fio2 was 100% and the sweep gas was turned up to 10 lpm.Multiple blood gases were performed due to the concerns about the oxygenator performance.They were contemplating changing out the oxygenator but the patient was almost warm so anesthesia ventilated which provided enough time to finish warming the patient and the team decided to just come off cpb since the heart was beating instead of changing out the oxygenator.No known impact or consequence to patient.The product was not changed out.Procedure was completed successfully.
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 april 29, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - updated lot number and added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 4210, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 4210 - leakage/seal.Conclusions code: 4315 - cause not established.The actual sample was not returned for evaluation.However, the video recorded during the event showed that bubbles and pink color liquid were flowing out from the fiber on the gas-out side of the actual oxygenator.Review of the dhr and incoming inspection record of the involved material code/lot number confirmed that there were no indications of anomalies.A review of the performance test results related to the involved fiber lot number confirmed no anomaly noted.Based on the video provided shows that plasma leaked occurred in the sample.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: STERILE FX15REC W/ 3L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10012235
• Report Number: 1124841-2020-00103
• Device Sequence Number: 3303550
• Product Code: DTZ
• UDI-Device Identifier: 00699753450806
• UDI-Public: (01)00699753450806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 10/31/2022
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: XN04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 73