• 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 NS FX15RWC 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 NS FX15RWC W/4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*FX15RW40CA
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2019
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 prior to cardiopulmonary bypass, a clotting issue was observed. After the patient was cannulated the patient, blood was sucked out of the chest cavity into the cardiotomy. The act was at 550. After a few minutes, a clot was noticed at the bottom of the cardiotomy, in the tubing going to the centrifugal pump, and to the one way valve. It was decided to cancel and reschedule the surgery instead of changing out the product. More testing on the patient was to be done to determine what may have caused clotting. There was no patient injury or blood loss reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNS FX15RWC 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 Key8971452
MDR Text Key156803399
Report Number1124841-2019-00250
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151389
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,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model Number3ZZ*FX15RW40CA
Device Catalogue NumberN/A
Device Lot NumberXE22
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2019
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: 09/06/2019 Patient Sequence Number: 1
-
-