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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Information (3190)
Event Date 02/27/2019
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, formed clots was observed in the cardiotomy portion of the reservoir. It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery. Terumo continues to attempt to gain more information regarding this event from the user facility.
 
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Brand NameSTERILE FX25REC W/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
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key8458099
MDR Text Key140150135
Report Number1124841-2019-00084
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberWD26
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2018
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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