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

Catalog Number 004192

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

No product has been returned, therefore we are unable to confirm the reported problem.Based on available information, no corrective actions will be taken at this time.Smiths medical regularly analyzes complaint data and trends, and will take further actions accordingly.

Event Description

It was reported that there was an occlusion with the celo set.The patient's blood glucose level rose to a level of 325 mg/dl as a result.The patient injected a manual bolus to correct for the high blood glucose level.No further complications were reported.

• 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 MEDICAL ASD, INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7507747
• MDR Text Key: 108021935
• Report Number: 3012307300-2018-10082
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 004192
• Device Lot Number: 74X184
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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