Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL TRIFUSE; IV ADMIN SET
  • 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
 

ICU MEDICAL TRIFUSE; IV ADMIN SET Back to Search Results
Model Number K181-001
Device Problem Blocked Connection (2888)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2017
Event Type  malfunction  
Event Description
The nurse observed a piece sticking out of the clave of the smallbore trifuse ext set.Upon picc line assessment, the nurse noted that clave closest to the patient had the inside part protruding out without any leaking to be evident.No adverse patient consequences were reported.The device was not returned, therefore no testing of the actual device could occur.A two-year review of the complaint database list k181-001 with similar problems revealed no additional reports.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIFUSE
Type of Device
IV ADMIN SET
Manufacturer (Section D)
ICU MEDICAL
4455 atherton drive
salt lake city UT 84117
Manufacturer (Section G)
ICU MEDICAL
4455 atherton drive
salt lake city UT 84117
Manufacturer Contact
holly imes
4455 atherton drive
salt lake city, UT 84117
8012641747
MDR Report Key6912909
MDR Text Key89648837
Report Number2025816-2017-00214
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00887709036512
UDI-Public887709036512
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberK181-001
Device Catalogue NumberK181-001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-