• 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, INC. PRIMARY PLUM 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
 

ICU MEDICAL, INC. PRIMARY PLUM SET IV TUBING Back to Search Results
Model Number 14687-28
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Death (1802)
Event Date 11/15/2018
Event Type  Death  
Event Description
Iv tubing primary plum set clave port, clave y-site, secure lock, 103 inch tubing, item #14687-28 was being utilized to infuse normal saline through the sheath of the pt's central line. The central line was in the pt's right internal jugular vein. The iv line disconnected from the secure lock and the pt hemorrhaged from the central venous catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRIMARY PLUM SET
Type of DeviceIV TUBING
Manufacturer (Section D)
ICU MEDICAL, INC.
600 north field dr bldg h2-1e
lake forest IL 60045
MDR Report Key8126008
MDR Text Key129170441
Report Number8126008
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number14687-28
Device Catalogue Number1468728
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/28/2018
Distributor Facility Aware Date11/15/2018
Event Location Hospital
Date Report to Manufacturer11/28/2018
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/29/2018 Patient Sequence Number: 1
-
-