MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 08/03/2020

Event Type  Death  

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a plasma leakage.As per the clinical perfusionist, while on cardiopulmonary bypass, a steady drip started to occur from the bottom of the oxygenator.Upon investigation, the condensation appeared to be tinted indicating a plasma leak.At this time they were still on cardiopulmonary bypass, and the leak appeared to have no effect on the function of the oxygenator.The patient's arterial oxygen levels and venous saturation levels remained adequate.The surgeon was notified upon finding.The patient was successfully removed from cardiopulmonary bypass with no incidence in regard to the leak.The issue did not result in delay of the procedure.We were able to successfully come of cardiopulmonary bypass with no additional incidence." additionally, as per the sales associate, the long bypass run over 5 hours, and they were on sucker bypass initially for approximately an hour.Foaming our gas out port.Then noticed it in the gas line (gas inlet) at conclusion of case during tear down.The patient died.Severe pulmonary edema as coming off bypass.As per the perfusionist, the plasma leak or oxy issue did not contributed to the patient's death.Product was not changed out.Procedure was completed successfully.

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 september 1, 2020.Upon further investigation of the reported event, the following information is new and / or changed: d4 (additional device information added exp date).G4 (date received by manufacturer).G7 (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, 3331, 4210, 4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 4210 - leakage / seal.Conclusions code: 4307 - cause traced to component failure.The returned sample was visually inspected upon receipt with no anomalies including a breakage that could lead to leak.The blood channel of the actual sample was filled with physiological saline (colored to improve visibility), and a pressure of 2 kgf / cm2 was applied and no leakage was found.Review of the manufacturing record and incoming inspection record of the involved material code / lot number confirmed that there were no anomalies.The performance test results of the fiber lot were reviewed with no anomalies.From past experiences the possible cause of the occurrence is likely that the blood properties changed due to some factor, a substance with a surface-active action was produced and the balance between the surface tension of the blood and gas maintained in the microscopes of the fiber was collapsed.This made the fibers hydrophilic, leading to plasma leak.It is likely that due to the increase in the internal pressure of the oxygenator module (during clotting, etc.),the pressure applied from the blood channel to the gas channel increased.This increased force with which the blood components tend to flow out to the gas channel, leading to plasma leak.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10475756
• MDR Text Key: 205073537
• Report Number: 1124841-2020-00204
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: YF04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 102