• 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
Catalog Number 21-7220-24
Device Problem Partial Blockage (1065)
Patient Problem Hyperglycemia (1905)
Event Date 07/10/2017
Event Type  Injury  
Manufacturer Narrative
See mfr: 3012307300-2017-02063.
 
Event Description
It was reported that the patient's pump alarmed for occlusion (alarm number in pump history: 26) during use of a cleo® 90 infusion set. The patient's blood glucose levels were 446 mg/dl at the time of the event. To address the high blood glucose levels, the patient administered an insulin bolus with the pump. The patient did not test for ketones. Through troubleshooting with the distributor, it was determined the blockage was located in the tubing. The patient was then able to replace the tubing, complete a load sequence, and resume insulin from the pump. No permanent injury was reported.
 
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.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, 22425
MX 22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6889966
MDR Text Key87197361
Report Number3012307300-2017-02064
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028335
UDI-Public10610586028335
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 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2022
Device Catalogue Number21-7220-24
Device Lot Number77X027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/25/2017 Patient Sequence Number: 1
-
-