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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*FX25RECA
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
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 after cardiopulmonary bypass, the oxygenator clotted. No patient involvement.
 
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Brand NameNS 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
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key12070542
MDR Text Key260451384
Report Number1124841-2021-00150
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3ZZ*FX25RECA
Device Catalogue NumberN/A
Device Lot NumberYN16
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2020
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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