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 COSTA RICA LTD. NO INFORMATION; SET, ADMINISTRATION, INTRAVASCULAR
  • 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 COSTA RICA LTD. NO INFORMATION; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number NO INFORMATION
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
It was reported, on an unknown date, that a microclave® clear neutral connector disconnected during use.As per the report, the teams are reporting an issue with the total parental nutrition (tpn) tubing.It is disconnecting unexpectedly.They have had senior staff verify the connections are secure, but they still seem to pop off.This has been a contributing factor in at least one clabsi.There was no patient harm reported.
 
Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NO INFORMATION
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS 
Manufacturer Contact
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18340845
MDR Text Key331059500
Report Number9615050-2023-00789
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00(01)(17)(10)
UDI-Public(01)(17)(10)
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNO INFORMATION
Device Lot NumberNO INFORMATION
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2023
Initial Date FDA Received12/15/2023
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
-
-