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

Model Number 3CX*FX15RW30C

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the level sensor failed to alarm indicating that the venous reservoir was empty causing air to enter boot pump.Per facility, blood returning via the cardiotomy suction flowed down the reservoir wall over the sensor location & was believed to be the reason for noalarm & that the pump did not stop.The level sensor is positioned on the back of the oxygenator reservoir.The bubble alarm did not activate.A micro bubble alert occurred during repriming of the oxygenator through the recirculation line, but not enough air to stop the pump on a medium setting.The bubble alarm is positioned immediately post oxygenator.Due to the level sensor being on the back of the reservoir, the blood level and sensor cannot be seen at the same time.No patient involvement.The product was not changed out.The surgery was completed successfully.

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 september 27, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 4114, 213, 67).Type of investigation: 4114 - device not returned.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The complaint details, provided videos and photos were reviewed.It was determined that the level sensor was placed on an angled surface of the reservoir.Level sensors are meant to be placed on a flat surface to be aligned with the side scale labels to ensure proper operating volume.As the level sensors are placed on the reservoir by the user, it has been determined that there is no product deficiency.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information was received.The event occurred during cardiopulmonary bypass and there was no harm to the patient.

• 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15494536
• MDR Text Key: 301032024
• Report Number: 1124841-2022-00155
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SORIN LEVEL SENSOR