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

Model Number 3CX*FX15RW30C

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/15/2023

Event Type  Injury  

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.For this reason, terumo references evaluation conclusion code 11.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a defect in the oxygenator causing excessive flow resistance.As per the lead perfusionist, he experience the clinical presentations of an oxygenator failure.Upon initiating bypass, line pressure, flow rate, and rpm's, they were within normal range.After roughly 3-4 minutes he noticed a consistent decrease in arterial line pressure and flow rate which required an increase in rpm's to maintain normal flows.At this point, he confirmed there were no open shunts within the circuit.Additionally, he felt that the oxygenator inlet line was highly pressurized.By the time they made the decision to change the oxygenator, the rpm's were nearly maxed out around 3500-3700 with a subsequent flow rate of 2.6 lpm.The act was in therapeutic range, leading them to believe that there was a defect in the oxygenator fibers causing excessive flow resistance.There was a delay, as the changeout lasted approximately 3 minutes while the patient temperature was 30 degrees celsius.*no consequence or health impact to patient.*there was a blood loss for approximately 250 ml *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 january 12, 2024.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, 213, 67).The affected sample was visually inspected upon receipt, no breakage or external anomaly leading to increasing pressure was observed.After it was rinsed and dried, the unit was tested for pressure drop with bovine blood.It was confirmed that a maximum blood flow rate of 5 l/min could be obtained, and the pressure drop was able to meet the factory's specifications with no obstruction found.Saline solution was flowed in the blood channel.As a result, no formation of blood clot was confirmed.As a cause of the occurrence, it was likely that the blood-derived obstruction occurred for some reason.However, with no anomalies found in the actual sample, a possible root cause could not be determined.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
• 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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 18505519
• MDR Text Key: 332801725
• Report Number: 1124841-2024-00010
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• 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
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 3G19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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
• Patient Outcome(s): Other