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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 Problems Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
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); (b)(4). Results: results pending completion of investigation; conclusions:conclusion not yet available.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a plasma leakage occurred. Per used facility, the procedure was a reconstruction of the mitralis valve with the da vinci robot. The amount of blood loss was minimal, about 230ml, but was recovered by the cell saver. The total cpb-time was: 376 min and clamp time 230 min. After about 300 min the plasma leakage was detected, see also attached movies. The temperature of the patient was at that moment 31° c. There was no problem with the gas exchange performance, no issues seen. The product was not changed out; the surgery was 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 Key11065231
MDR Text Key223407068
Report Number1124841-2020-00292
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,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*NX19RE
Device Catalogue NumberN/A
Device Lot NumberYM05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2020 Patient Sequence Number: 1
Treatment
CELL SAVER
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