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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 Injury (2348); Blood Loss (2597)
Event Date 03/04/2020
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).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was plasma leakage at gas inlet and gas outlet side. Per user facility, the report documents the event and online data for a longer case with two sessions; first for approx. 6. 5h (including perfusion/reperfusion, etc) and second for approx. 1. 75h. In the second session, a plasma leakage was discovered and a second oxygenator was added after approx. 0,25h perfusion time. The first session stopped @16:40 local time. The second session started @ 19:04 local time and stopped @ 20:47 local time; plasma leakage observed and 2nd oxy added. There is no act/heparin info documented since the last act value (@16:11). The plasma leakage was observed during the second session therefore it appears that the oxy was already in use (first session + standby) for approx. 9h before the second session started. There was around 1 minute delay. There was less than 100ml blood loss + plasma leakage about 200ml. The product was 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
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key9918042
MDR Text Key200833119
Report Number1124841-2020-00080
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
Report Date 05/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number3CX*NX19RE
Device Catalogue NumberN/A
Device Lot NumberXL16
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2019
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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