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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
Event Date 05/11/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and 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
The distributor reported that a female patient using cleo infusion set noted blood in tubing at time of high blood glucose exceeding 600mg/dl, and a moderate level of ketones.The patient was treated in the emergency room after symptoms of rapid breathing, extreme thirst, abdominal pain, nausea, vomiting, strong fruity breath, chest pain, extreme drowsiness, blurred vision, excess urination, dizzy and lightheadedness.The patient received insulin via injection and iv fluids.Unknown condition of patient at the time of report.
 
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Brand Name
CLEO® 90 INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.,
1265 grey fox rd
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.,
1265 grey fox rd
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox rd
st. paul, MN 55112
7633833052
MDR Report Key5739852
MDR Text Key47891125
Report Number2183502-2016-01221
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 Other
Type of Report Initial
Report Date 05/24/2016
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/24/2016
Initial Date FDA Received06/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
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