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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 Partial Blockage (1065); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
The reporter noted "for the past month or so" and that event date was approximate. Potential lot number: 76x145. Potential expiration date: 08/28/2021. Potential device manufacturer date: 09/01/2016. 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 cleo® 90 infusion set had a site failure. The patient specified that the infusion set cannula was blocked inside the tubing due to the patient shedding skin. When the cannula was removed, no issue with the cannula was observed. The patient noted that there was an issue with absorption as the device had to be changed out between 1 and 1. 5 days rather than 3 days. Due to the incident, the patient's blood glucose was reported to be at approximately 400mg/dl. The patient noted that he had a small trace of ketones. A corrective bolus was administered to address the high blood glucose. The patient stated that his blood glucose was in a normal range at this time. No permanent injury was reported. See mfr: 3012307300-2017-00875, 3012307300-2017-00876, 3012307300-2017-00877, 3012307300-2017-00878, 3012307300-2017-00879, 3012307300-2017-00880, 3012307300-2017-00881, 3012307300-2017-00882, 3012307300-2017-00883, 3012307300-2017-00884, 3012307300-2017-00885, 3012307300-2017-00886, 3012307300-2017-00887, 3012307300-2017-00888, 3012307300-2017-00889, and 3012307300-2017-00890.
 
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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, 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6513940
MDR Text Key73449128
Report Number3012307300-2017-00890
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 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7220-24
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 Received03/30/2017
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: 04/22/2017 Patient Sequence Number: 1
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