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

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.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, 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 Key: 6513870
• MDR Text Key: 73449269
• Report Number: 3012307300-2017-00886
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• 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,distributor
• Reporter Occupation: Other
• 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 Received: 04/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7220-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR