MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

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 2183502-2016-01892.

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 2183502-2016-01892.

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).

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, 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 Key: 5929585
• MDR Text Key: 53950858
• Report Number: 2183502-2016-01891
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• 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 Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention