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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number CLEO 90
Device Problem Device Issue (2379)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/11/2015
Event Type  Injury  
Event Description
It was reported that a customer had issues with a cleo 90 infusion set.Customer reported high blood sugar levels of 562 mg/dl and used correction bolus to stabilize the blood sugar.Minimal troubleshooting was performed so as to not disturb customer during their sleep.Customer was sick with the flu and is currently taking (b)(6).Cts stated that being ill and taking new medication could affect blood sugars due to changes in body chemistry.No injury reported.
 
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Brand Name
CLEO® 90 INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD INC
1265 grey fox road
st paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7508297
MDR Text Key108039052
Report Number3012307300-2018-10006
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 Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCLEO 90
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/13/2015
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 N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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