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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE40C
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 08/14/2018
Event Type  malfunction  
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.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, approximately 2 hours into a 5 hour pump run, condensation and fluid were observed inside the end cap of the oxygenator. There was also fluid dripping around the end cap and some blood in the gas inlet line to the oxygenator. Blood loss amount is unknown. Product was not changed out. 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 september 4, 2018. (b)(4). The sample was not returned for evaluation, however, a video showing the complaint was provided for review. A retention sample was visually inspected and did not reveal any obvious anomaly such as a break. The retention sample was also built into a circuit with tubes and saline solution was circulated in the circuit at the flow rate of 5l/min. No leak was observed. Subsequently, the circuit was circulated with bovine blood for 6 hours at the flow rate of 5l/min and at the back pressure of 500 mmhg. After the 6-hour circulation, a gas was sent into the gas phase. No leak was observed. A review of the video confirmed the event. The presence of foamy fluid was noted around the gas phase. Based on the review result of the provided video, it is likely that a plasma leak took place in the actual sample. With the absence of the actual sample to evaluate, however, it is difficult to determine the definitive cause of this complaint. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameSTERILE FX15REC W/ 4L RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key7844858
MDR Text Key119153110
Report Number1124841-2018-00213
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450813
UDI-Public(01)00699753450813
Combination Product (y/n)N
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model Number3CX*FX15RE40C
Device Catalogue NumberN/A
Device Lot NumberWF28
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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