MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO 90 INFUSION SET 31"; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Device Displays Incorrect Message (2591); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Email from (b)(6), cnss: i received a call from pt stating her infusion was alarming occlusion, we attempted to troubleshoot over the phone, to no avail.I made a visit to find her cleo was bent causing the occlusion.I decided to change her to the silhouette as she has very little fatty tissue.No other information or dates provided/available.Lot/exp unknown and unknown if available for investigation.

• Brand Name: CLEO 90 INFUSION SET 31"
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 9910056
• MDR Text Key: 186139123
• Report Number: MW5093989
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1