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

Catalog Number 21-7231-24

Device Problems Device Alarm System (1012); Partial Blockage (1065)

Patient Problem Hyperglycemia (1905)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2017-01910.

Event Description

It was reported that a patient encountered an occlusion alarm while using a cleo 90 infusion set.Troubleshooting determined blockage was likely at the site.The patient was instructed to remove site to observe the cannula.The patient stated the cannula was not compromised.Issue likely underneath the skin.Patient changed infusion set and resumed insulin delivery.Blood glucose was 336 mg/dl.Patient delivered a 10 unit bolus and confirmed all units were successfully delivered.Patient's high blood glucose level was resolved.No other serious injuries were reported.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINSTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6805288
• MDR Text Key: 83062951
• Report Number: 3012307300-2017-01911
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 76X122
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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: 78 YR