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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE30C
Device Problem Decrease in Pressure (1490)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2020
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. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a great decrease in the performance of oxygenation occurred, due to a revision of the mitral prosthesis 90 minutes in cec. Additionally, it was necessary to increase almost to the maximum the gas exchange. They increased sweep gas flow to a higher flow as used to do during ecmo (extracorporeal membrane oxygenation) to remove the condesa. No known impact or consequence to patient. Product was not changed out. Procedure was completed successfully.
 
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Brand NameSTERILE FX15REC W/ 3L RES
Type of DeviceBLOOD 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 Key10501972
MDR Text Key205931211
Report Number1124841-2020-00213
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number3CX*FX15RE30C
Device Catalogue NumberN/A
Device Lot NumberWM08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
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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