MAUDE Adverse Event Report: SMITHS MEDICAL CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Obstruction of Flow (2423); Device Displays Incorrect Message (2591)

Patient Problems Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 02/27/2013

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on february 28, 2013, a nurse reported a patient was hospitalized on (b)(6) 2013, with diabetic ketoacidosis.He experienced recurrent e4 occlusion and e7 electronic errors on the infusion device.He was unwell and not very responsive, and he was treated with an insulin drip.This occurred in the united kingdom and was reported by an affiliate, and the patient's information was not provided.The cleo infusion set mentioned in this event is not manufactured by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 17523500
• MDR Text Key: 321138402
• Report Number: MW5130448
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1