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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION FX15E PRESCRIPTIVE OXY SUB BLOOD GAS OXYGENATOR Back to Search Results
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.
 
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Brand NameFX15E PRESCRIPTIVE OXY SUB
Type of DeviceBLOOD 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 Key5403895
MDR Text Key37307487
Report Number1124841-2016-00051
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140774
Number of Events Reported1
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 Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCXOT160
Device Lot NumberTG22
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 Received01/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2015
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
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