• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problems Injury (2348); Blood Loss (2597)
Event Date 03/02/2020
Event Type  Injury  
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 not enough oxygenation after 1 hour and 21 minutes on bypass. As per the user facility, an initial dose of 10. 000 iu of heparin was documented for the priming only. Then an initial act of 999 sec was documented after 15 minutes on bypass. The report documents usage of hemofiltration, close to the entire documented perfusion time, with a high total amount of hemofiltration of (12. 000 ml). Furthermore the provided case report documents lower level of hgb and hct during the case. There was a 1 minute delay for they changed out the hlm (heart lung machine) with the new oxygenator. There was a blood loss of 100 ml. Procedure completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9911326
MDR Text Key185975030
Report Number1124841-2020-00078
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
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
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

Patient Treatment Data
Date Received: 04/01/2020 Patient Sequence Number: 1
Treatment
STÖCKERT S5 - HLM 5SORIN 3T LH 1
-
-