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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
Device Problem Bent (1059)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 12/25/2017
Event Type  Injury  
Manufacturer Narrative
See mfr: 3012307300-2018-00125.
 
Event Description
It was reported that the patient experienced high blood glucose levels during use of a cleo® 90 infusion set. The patient was admitted to the hospital for high blood glucose levels and diabetic ketoacidosis. The patient's blood glucose levels were over 500mg/dl at the time of the event. The patient's supplies had been in use for less than one day at the time of the event. Prior to hospitalization, the patient administered pump boluses and a temp rate of 150%. In the hospital, the patient received an intravenous insulin drip. Treatment resolved the issue. Upon removing the site in the hospital, it was observed the cannula was bent. The bent cannula was determined to have likely contributed to the event. No permanent injury was reported.
 
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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 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 Key7221961
MDR Text Key98331397
Report Number3012307300-2018-00126
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
Type of Report Initial
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/10/2018
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

Patient Treatment Data
Date Received: 01/26/2018 Patient Sequence Number: 1
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