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

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CLEO® 90 INFUSION SET 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
 

SMITHS MEDICAL ASD INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Device Alarm System (1012); Partial Blockage (1065)
Patient Problems Hyperglycemia (1905); Vomiting (2144)
Event Date 08/06/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a cleo® 90 infusion set had occlusion alarms (alarm number 2). Blood glucose was adversely affected and reported at 472mg/dl. An insulin injection was used to address the high blood glucose. The patient vomited, but had stopped since blood glucose levels dropped down. Device troubleshooting determined there was blockage at the site due to compromised cannula. The infusion site was replaced. No permanent injury was reported. See mfr: 2183502-2016-01904 and 2183502-2016-01905.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox rd.
st. paul, MN 51122
7633833074
MDR Report Key5932777
MDR Text Key54072104
Report Number2183502-2016-01903
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Reporter Occupation
Type of Report Initial
Report Date 08/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2016
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 Unkown

Patient Treatment Data
Date Received: 09/07/2016 Patient Sequence Number: 1
-
-