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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 Inadequacy of Device Shape and/or Size (1583)
Patient Problems Fever (1858); Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 07/14/2016
Event Type  Injury  
Event Description
The third emergency room visit was again on (b)(6) 2016 in which the patient was then hospitalized. The patient's white blood cell count was tested and the patient was diagnosed with diabetic ketoacidosis. The patient received iv novolog, potassium and saline. The blood glucose levels were above 300mg/dl and had large ketones levels which was identified as dangerous/life threatening. When the patient left the emergency room for admission to the hospital ((b)(6) 2016), they were sleepy and a low grade fever was present. It was reported that the patient's cannula was the wrong cannula type. The patient's site was a "90 degree" cannula and it was reported that the patient was too lean for that degree cannula. The cartridge and infusion set were in use less than a day and were changed a couple times. There were no alerts and alarms noted, and correction boluses used as normal. It was reported that the patient's temp rate was used at 150% prior to the hospitalization per health care providers orders and the basal had no change. The patient was discharged from the hospital on (b)(6) 2016 with a "30 degree" infusion set recommendation. No additional information was reported on the patient's condition at this time. Please reference mdr numbers 2183502-2016-01821 and 2183502-2016-01822 for other associated events.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5904377
MDR Text Key53014899
Report Number2183502-2016-01823
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 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2016
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 Initial

Patient Treatment Data
Date Received: 08/25/2016 Patient Sequence Number: 1
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