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

Device Problem Bent (1059)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 12/25/2017

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2018-00125.

Event Description

It was reported that the patient experienced high blood glucose levels during use of a cleo® 90 infusion set.The patient was admitted to the hospital for high blood glucose levels and diabetic ketoacidosis.The patient's blood glucose levels were over 500mg/dl at the time of the event.The patient's supplies had been in use for less than one day at the time of the event.Prior to hospitalization, the patient administered pump boluses and a temp rate of 150%.In the hospital, the patient received an intravenous insulin drip.Treatment resolved the issue.Upon removing the site in the hospital, it was observed the cannula was bent.The bent cannula was determined to have likely contributed to the event.No permanent injury was 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7221961
• MDR Text Key: 98331397
• Report Number: 3012307300-2018-00126
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 73