MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed bubbles coming up through the reservoir from the centrifugal inlet.As per user facility, while recirculating, they noticed bubbles coming up through the reservoir from the centrifugal inlet.Bubbles were also seen in the rear, seen both from front and back.And when we stopped recirculating, the venous line de-primed by a foot or more.This occurred with shunts closed.The pump was changed out.They double-checked all the luers and connections and were tightly closed.When the system was running, its negative pressure on the venous line likely caused cavitation of microbubbles into the fluid-filled part of the reservoir.This issue persisted even with a large amount of circulating prime volume so the point of entry for air must have been closer to the top of the venous inlet tube.When the system was turned off, being open to air somewhere along the tube allowed the venous line to completely de-prime.It is unknown if there was a delay, if the surgery was completed successfully, if it caused or contributed to an injury to the patient or if there was a blood loss.Terumo continues an attempt to gain more information regarding this event from the user facility.Product was changed out.

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).

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 28, 2022.Upon further investigation of the reported event, the following information is new and/or changed: health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.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 Description

New information received.There was no delay, the surgery was completed successfully, it did not caused or contributed to injury and no blood loss.

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: 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).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned; therefore, a thorough investigation could not be performed and a definitive root cause could not be determined.A representative retention sample was obtained and tested and found to function as intended.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: 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: 14242419
• MDR Text Key: 291314326
• Report Number: 1124841-2022-00097
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2022

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 Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2A17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/04/2022; 07/27/2022
• Supplement Dates FDA Received: 05/20/2022; 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1