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

Device Problem Delivery System Failure (2905)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

No units for weight given.Chose lbs.

Event Description

It was reported that a patient had an issue with a cleo® 90 infusion set falling off since the use of a pump.The blood glucose reading at the time of the event was 50 - 500.The patient delivered a corrective bolus to address the high blood glucose.The event did not cause any patient injury.Additional information reports that the patient has a type of diabetes where his cells randomly produce insulin without any pattern; so his blood glucose fluctuates rapidly.Patient said he's confirmed this with his health care provider and they are working on adjusting his settings to complement this condition.Patient stated this issue is due to this condition and not necessarily due to the pump or supplies.

• 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 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: 7240558
• MDR Text Key: 98978617
• Report Number: 3012307300-2018-00189
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• 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
• Treatment: NOVOLOG
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100