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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 Problems Device Alarm System (1012); Partial Blockage (1065)
Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 08/08/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. 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
It was reported that a patient was hospitalized while using a cleo 90 infusion set. The patient placed his pump in a cooler after receiving temperature alarms, but was unaware of the occlusion alarms and meaning of the occlusion alarm. The patient was taken to the hospital after showing signs of diabetic ketoacidosis (dka), high blood glucose, and vomiting. He was hospitalized for dka. Blood glucose was reported at 428mg/dl. A system check for occlusion was conducted on (b)(6) 2016 and blockage was observed at the site. The patient was removed from the pump and given manual injections of insulin therapy to resolve the blood glucose issue. A review of the pump history showed temperature alarms and occlusion alarms. The patient reported the bolus settings, temperature rate, and basal settings were unchanged. Blood glucose levels decreased from time of hospital admission. 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.
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox rd.
st. paul, MN 51122
7633833074
MDR Report Key5947394
MDR Text Key54625420
Report Number2183502-2016-01953
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 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received08/17/2016
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 Unkown

Patient Treatment Data
Date Received: 09/13/2016 Patient Sequence Number: 1
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