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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 Problems Bent (1059); Kinked (1339); Occlusion Within Device (1423)
Patient Problem Hyperglycemia (1905)
Event Date 11/12/2016
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 a patient using a cleo® 90 infusion set, experienced high blood glucose due to a bent cannula. The patient's blood glucose level was "275" at the time. The report stated that the patient will be administered an insulin bolus to resolve their high blood glucose. During trouble shooting with the reporter, that the patient was requested to examine the infusion site and found that the cannula was bent. There was also a pump occlusion alarm 2 noted at 1:49 am. According to the reporter, the patient was requested to change out the infusion set, in order to deliver the corrected bolus to resolve their high blood glucose. The patient was further instructed to change supplies and resume insulin.
 
Manufacturer Narrative
Please note additional/corrected information: additional information was received from the initial reporter which stated that this file is a duplicate of mfr# 3012307300-2017-00021. As this file is a duplicate it is no longer considered a complaint and is therefore not a reportable event.
 
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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, MN 55442
7633833074
MDR Report Key6228896
MDR Text Key64051470
Report Number3012307300-2017-00018
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,Followup
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Catalogue Number21-7220-24
Device Lot Number76X086
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 Received01/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
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: 01/06/2017 Patient Sequence Number: 1
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