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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 21-7231-24
Device Problem Partial Blockage (1065)
Patient Problem Hyperglycemia (1905)
Event Date 06/13/2017
Event Type  Injury  
Event Description
The patient's blood glucose returned to target levels after issue was reported.
 
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 after changing out all supplies, the patient experienced occlusion alarms (alarm number in pump history: 2) during use of a cleo¿0 infusion set. Through troubleshooting with the distributor, it was determined the blockage was likely located at the site. The patient's blood glucose levels were 245mg/dl at the time of the event. To address the high blood glucose levels, the patient administered a bolus and manual injection. The patient did not test for ketones. No permanent injury was reported. See mfr: 3012307300-2017-01403.
 
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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
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6678447
MDR Text Key105370148
Report Number3012307300-2017-01402
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028403
UDI-Public10610586028403
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 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2013
Device Catalogue Number21-7231-24
Device Lot Number71X008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2011
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: 06/29/2017 Patient Sequence Number: 1
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