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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 Use of Device Problem (1670)
Patient Problem 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 were not enough oxygenation. Per user facility the act/heparin management is well documented in the report. The maximum act of 640 sec is documented (49. 000 iu heparin administered). Pre & post pressures are continuously rising since bypass start and after approx. 15 to 20 min. Both pressures are showing close to doubled values. There was a blood loss of less than 100ml. There was around a delay of 1 minute. Product was changed out. Procedure 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 Key9918015
MDR Text Key200832823
Report Number1124841-2020-00079
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeSZ
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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