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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
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. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed to oxygenate. Emergent return to cpb due to failing abp & arterial saturations. The patient was weaned from bypass at 1516 with anesthesia managing oxygenation, ventilation, and blood pressure while the change out was completed. Total time required for changeout from separation to reinstitution of cpb was approximately 5 mins. Cpb was reinstituted at 1521 without incident. Post procedure, the failing oxygenator was visually inspected and there were no visual signs of gross clot observed. After washout, there appeared to be some evidence of fibrin formation/deposition on the fiber bundle, but no gross clot visible. The residual blood flowed freely from the oxygenator's ports. During the failure, a secondary gas source was used (oxygen cylinder) to confirm that the pumps gas supply was not the issue. Failure was confirmed via arterial blood gas. It is important to note that at no time was there any change in flow/pressure within the circuit or evidence of clotting within the venous reservoir or centrifugal pump head. No known impact or consequence to patient. Product was changed out with approximately 5 minutes delay. Procedure was completed successfully.
 
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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 Key12632815
MDR Text Key276471184
Report Number1124841-2021-00237
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,Followup,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
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 NumberZC01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
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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