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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

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 after cardiopulmonary bypass, foaming in the oxygenator was observed.As per the clinical specialist, the user facility stated that, after approximately one hour on cpb the blood gases were fluctuating.They added a second oxygenator into the recirculation line when the po2 values reached 60 - 65 mmhg.As per the director of perfusion, the time on cardiopulmonary bypass was 300 minutes.No consequence or impact to patient.

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 june 10, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp 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, 3331, 4210, 4307) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 4210 - leakage/seal investigation conclusions: 4307 - cause traced to component failure the returned sample was visually inspected with no break or any anomalies that could lead to leak.After having been rinsed, it was filled with physiological saline solution, and then tested for leakage by air of 2kgf/cm2 being applied.No leak was observed.Based on the investigation result, as a cause of the reported event, it was presumed that the plasma leak occurred leading to liquid flowing to the gas side.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: 11973721
• MDR Text Key: 260481718
• Report Number: 1124841-2021-00136
• 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: 07/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: ZD15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1