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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RWC
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the actual device; 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).
 
Event Description
The customer reported to terumo cardiovascular that after cardiopulmonary bypass, there was a white clot in the oxygenator. Procedure was completed successfully. No known impact or consequence to patient.
 
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 december 15, 2016. A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusion code. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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. (b)(4). The oxygenator sample and reservoir were returned with two containers filled with biological samples. The bottles were sent to an outside lab. Pathology testing was performed on the biological samples. The analysis resulted in unidentified foreign debris present within the clotted blood sample. The character of the foreign material present is not specific for a specific substance and the material was not able to be identified by light microscopy. Key features of the material include areas of fibrillar to filamentous material. The oxygenator sample was returned to (b)(4) for evaluation. The sample was built into a circuit where bovine blood was circulated and the pressure drop was determined at each flow rate. The obtained values met all specifications and no clots were found. The bovine blood was then circulated for 6 hours, no clots were found. The bovine blood was then rinsed and visually inspected, no clots were found in the device. A review of the device history record revealed no manufacturing anomalies. The reported event was not able to be replicated; therefore, a definitive root cause was not able to be determined and this complaint is not confirmed. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameSTERILE FX25RWC W/ RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6178724
MDR Text Key62532930
Report Number1124841-2016-00429
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberUK29
Other Device ID Number(01)00699753450837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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