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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
Catalog Number 004198
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2015
Event Type  Injury  
Manufacturer Narrative
No product has been returned, therefore we are unable to confirm the reported problem. Based on available information, no corrective actions will be taken at this time. Smiths medical regularly analyzes complaint data and trends, and will take further actions accordingly.
 
Event Description
It was reported that there was an occlusion with the celo set. The patient's blood glucose level rose to a level of 311 mg/dl as a result. The patient injected a manual bolus to correct for the high blood glucose level. The patient's blood glucose was reduced to a level of 161 mg/dl after this intervention. The aforementioned information indicates that a serious injury occurred. Medical intervention was necessary in order to preclude permanent impairment of a body function or permanent damage to a body structure.
 
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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 MEDICAL ASD INC
1265 grey fox road
st paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7507752
MDR Text Key108021772
Report Number3012307300-2018-10128
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
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? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number004198
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 Received01/04/2016
Was Device Evaluated by Manufacturer? No
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: 05/11/2018 Patient Sequence Number: 1
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