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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DIANA; COMPOUNDER
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ICU MEDICAL DIANA; COMPOUNDER Back to Search Results
Model Number V1.1.X.X
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 11/30/2015
Event Type  malfunction  
Event Description
Patient admitted to pediatric emergency room in dka.A drip containing regular insulin 100 units/100ml ns compounded by the hospital pharmacy using icu medical device diana was started at approximately 2200 (b)(6) 2015 at a dose of 0.1 units/kg/hr intravenously.The patient was transferred to picu.The bag was changed out on the floor approximately 1 hour later.The patient's serum glucose reduced approximately 40% over 19 hours.The covering endocronologist suspected the insulin drip did not contain the labeled amount of regular insulin.A fresh bag was started (b)(6) 2015 at 1838.The patient's serum glucose reduced by 65% within 3 hours.The patient continued on the same dose until (b)(6) 2015, 1350.The patients serum glucose reduced to 216 during this time period.The discharge serum glucose was 161.Dates of use: (b)(6) 2015.Reason for use: dka with elevated serum glucose.Event abated after use: yes.
 
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Brand Name
DIANA
Type of Device
COMPOUNDER
Manufacturer (Section D)
ICU MEDICAL
san clemente CA 92673
MDR Report Key5394086
MDR Text Key37115617
Report NumberMW5059661
Device Sequence Number1
Product Code NEP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV1.1.X.X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age8 YR
Patient Weight32
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