MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION FX15E PRESCRIPTIVE OXY SUB BLOOD GAS OXYGENATOR

Model Number CXOT160

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Blood Loss (2597)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Terumo has not received the actual 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 more information becomes available. (b)(4). Conclusion not yet available - evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass the oxygenator began to exhibit reduced flow. Multiple attempts were made to improve flow; however, despite increasing centrifugal pump speed, flow would not increase above 1. 5 liters/min. The oxygenator was changed out for an fx25e. Terumo was informed that the patient had previously had clotting issues and a-fib. Blood loss of approximately 100cc. Product was changed out. It is unknown whether the surgery was completed successfully.

• Brand Name: FX15E PRESCRIPTIVE OXY SUB
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5403895
• MDR Text Key: 37307487
• Report Number: 1124841-2016-00051
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CXOT160
• Device Lot Number: TG22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/02/2016 Patient Sequence Number: 1