• 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, ADMINSTRATION, 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, ADMINSTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7231-24
Device Problems Device Alarm System (1012); Partial Blockage (1065)
Patient Problem Hyperglycemia (1905)
Event Date 07/24/2017
Event Type  Injury  
Manufacturer Narrative
See mfr: 3012307300-2017-01910.
 
Event Description
It was reported that a patient encountered an occlusion alarm while using a cleo 90 infusion set. Troubleshooting determined blockage was likely at the site. The patient was instructed to remove site to observe the cannula. The patient stated the cannula was not compromised. Issue likely underneath the skin. Patient changed infusion set and resumed insulin delivery. Blood glucose was 336 mg/dl. Patient delivered a 10 unit bolus and confirmed all units were successfully delivered. Patient's high blood glucose level was resolved. No other serious injuries were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINSTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
avenida calidad no. 4
parque industrial internaciona
tijuana, baja california 22425
MX 22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6805288
MDR Text Key83062951
Report Number3012307300-2017-01911
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028403
UDI-Public10610586028403
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 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2021
Device Catalogue Number21-7231-24
Device Lot Number76X122
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/18/2017 Patient Sequence Number: 1
-
-