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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 Device Alarm System (1012); Failure To Adhere Or Bond (1031); Bent (1059); Hole In Material (1293); Leak/Splash (1354); Retraction Problem (1536)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
One cleo® 90 infusion set was returned for evaluation. Visual inspection showed the trocar to be in the retracted position and was considered used. Functional testing involved resetting the trocar and testing the device as intended. When the sleeve was compressed, the trocar retracted as designed. Based on the evidence, the device operated within manufacturing specifications and the complaint could not be confirmed. There was no evidence found to suggest the event was caused from an intrinsic defect in the product. The customer reported that six devices contributed to six reported events (one device per event). The customer returned one device for evaluation. It could not be determined which reported occurrence was related to the returned device; therefore, the evaluation of the returned device will be used for each medwatch follow-up. The following medwatches were submitted related to the investigation: 2183502-2016-01887, 2183502-2016-01887, 2183502-2016-01888, 2183502-2016-01889, 2183502-2016-01890, and 2183502-2016-01891.
 
Event Description
It was reported that cleo® 90 infusion sets would not attach correctly in the last few weeks from date of report. The click and auto-retract feature was a struggle for the patient and would not always happen. Upon pushing it again to make it click, it caused the cannula to get a hole in the side, bent the cannula tip leading to an occlusion alarm, or leaked insulin. Blood sugars were reported to rise up to 300mg/dl. A bolus of insulin or attaching another set was used to address the blood glucose at home. An insulin syringe with insulin extracted from the pump was administered to address the blood glucose when not at home. No permanent injury was reported. See mfr: 2183502-2016-01887, 2183502-2016-01888, 2183502-2016-01889, 2183502-2016-01890, and 2183502-2016-01891.
 
Manufacturer Narrative
One cleo® 90 infusion set was returned for evaluation. The customer reported that six devices contributed to six reported events (one device per event). It could not be determined which device was associated with which reported occurrence; therefore, the evaluation of the returned device will be used for this medwatch. Visual inspection found that the trocar was already in the retracted position. Functional testing involved resetting the trocar and testing the device, which showed that when the sleeve was compressed, the trocar retracted as designed without problem or difficulty. Based on the evidence, the complaint could not be confirmed and the device operated within specifications. There was no evidence found to suggest the event was caused from an intrinsic defect in the product. (b)(4).
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox rd.
st. paul, MN 51122
7633833074
MDR Report Key5929581
MDR Text Key53951221
Report Number2183502-2016-01892
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
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 08/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Yes
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 Unkown

Patient Treatment Data
Date Received: 09/06/2016 Patient Sequence Number: 1
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