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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905)
Event Date 08/29/2017
Event Type  Injury  
Manufacturer Narrative
See mfr: 3012307300-2017-02069.
 
Event Description
It was reported that the patient's pump alarmed for occlusion (alarm number in pump history: 2) during use of a cleo® 90 infusion set. The patient had tried changing out their tubing following the occlusion alarm, but occlusions continued. It was noted the patient wears a pump in a case in their pocket. The occlusion occurred during bolus delivery. The patient's blood glucose level was 145mg/dl at the time of the event. The patient had been using their cartridge/infusion set for less than three days. A soft cannula was used with the infusion set. The patient's cartridge was noted to be overfilled with insulin. The patient was advised to change their site. The patient also noted there was dried blood and bruising on their skin. After changing the site, the patient reported no further occlusions. No permanent injury was reported.
 
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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
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6889971
MDR Text Key87197262
Report Number3012307300-2017-02068
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 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2017
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

Patient Treatment Data
Date Received: 09/25/2017 Patient Sequence Number: 1
Treatment
NOVOLOG INSULIN
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