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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
Catalog Number 21-7220-24
Device Problem Kinked (1339)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Vomiting (2144)
Event Date 12/28/2016
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
It was reported that during the use of the cleo® 90 infusion set, the patient experienced two kinked cannulas. According to the reporter, the patient blood glucose rose to 545 mg/dl due to the reported event. The patient reportedly inserted a new infusion site, administered insulin injects, and delivered a bolus to resolve their high blood glucose. According to the report, the patient was administered to the emergency room on (b)(6) 2016, due to high blood glucose levels and large amount of ketones. It was stated that the patient's ketone levels were life threatening. After the emergency room visit, the patient was admitted to the hospital until (b)(6) 2016. It was reported that the patient had a blood glucose level of 350 mg/dl at the time of admittance to the emergency room. According to the report, the patient was at the emergency room for approximately 2 hours and received intravenous saline therapy and an insulin drip. The patient was reportedly dehydrated and vomiting when discharged from the emergency room. While in the hospital the patient received intravenous saline therapy and an insulin drip. It was reported that the cartridge and infusion set was in patient use for 2 days prior to the reported event; the insulin was in use for less than 28 days. No permanent adverse effects to patient reported. Related mfr#: 3012307300-2017-00306.
 
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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, bc 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6308864
MDR Text Key66727287
Report Number3012307300-2017-00307
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
Reporter Occupation
Type of Report Initial
Report Date 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Catalogue Number21-7220-24
Device Lot Number76X132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2016
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: 02/07/2017 Patient Sequence Number: 1
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