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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RE W/ 4L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RE W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*NX19RE
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the device for evaluation, however, 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, there was a plasma leakage. As per the sales associate, there was a negligible amount of blood loss and the customer resolve the issue by increasing the sweep to 2 to 4. As per the clinical specialist, the director of clinical specialist called the perfusionist on (b)(6) 2020. The perfusionist who started the case reported no issues during the hand off discussion. The plasma leak took place at the ending stages of the 5 hour and 13 minute procedure for a cabg x 4 aortic valve replacement procedure on a 72 y/o male. The perfusionist noted that this patient had been hospitalized 2 days prior to the surgery which is unusual, but he didn't know why. He didn't feel that the patient exhibited any inflammatory tendencies while on bypass although he did note that he needed to run his sweep gas higher than what he has experienced in the past, 3. 5 to 4 lpm versus 2lpm typically. It was not at all unmanageable and po2 was not affected at all, so during the conversation he concluded that it was most likely patient to patient variability. Another thing he noted was that the scavenge line on their boehringer vavd controller seemed to have more condensate than normal. But again, slower surgeon, potentially longer rewarm time. The patient was large - 102 kilos. They had to run a higher sweep than what they consider normal - 4 lpm versus typically running 2 lpm. Gas exchange performance was not a problem. There was a negligible amount of blood loss; the product was not changed out; procedure completed successfully.
 
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Brand NameSTERILE NX19RE W/ 4L 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 Key10848834
MDR Text Key216907918
Report Number1124841-2020-00265
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180950
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
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model Number3CX*NX19RE
Device Catalogue NumberN/A
Device Lot NumberXP30
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2020
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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