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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25RWC W/RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25RWC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*FX25RWCA
Device Problem Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was not oxygenating the patient well. It is unknown whether there was patient effect or injury to the patient as a result of the procedure. Terumo continues to attempt to gain more information regarding this event from the user facility. The product was changed out. The surgery was completed successfully.
 
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).
 
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Brand NameNS FX25RWC 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
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key14203947
MDR Text Key290961695
Report Number1124841-2022-00093
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3ZZ*FX25RWCA
Device Catalogue NumberN/A
Device Lot Number2C14
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/16/2022
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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