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

MAUDE Adverse Event Report: CAREFUSION CAREFUSION SMARTSITE INFUSION SET IV TUBING

  • 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
 

CAREFUSION CAREFUSION SMARTSITE INFUSION SET IV TUBING Back to Search Results
Catalog Number 2426-0007
Device Problems Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979)
Patient Problem No Information (3190)
Event Date 02/20/2018
Event Type  malfunction  
Event Description
Iv pump showed error message "occlusion pt side. " large bulge bubble noted in tubing with no pt side occlusion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAREFUSION SMARTSITE INFUSION SET
Type of DeviceIV TUBING
Manufacturer (Section D)
CAREFUSION
317 sarl
rolle ch CH-11 80
MDR Report Key7316631
MDR Text Key101772405
Report NumberMW5075676
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2020
Device Catalogue Number2426-0007
Device Lot Number17087705
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-