MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INFUSION SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Leak/Splash (1354)

Patient Problems Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous.Pt reports that she noticed that last few tubings had medication leaking from them dates unknown.Pt did not have serial, lot numbers of tubing available.Pt reported when used new tubing from latest dispense, she experienced side effects of congestion and lightheadedness, possibly due to the correct higher dose of remodulin being administered through intact tubing.Pt reported she stopped infusion date unknown, advised pt to restart at half the pump rate and titrate back to maintenance rate as tolerated.Advised pt to contact md if symptoms persist.No other information known.Reported to (b)(6) by pt/caregiver.

• Brand Name: INFUSION SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12744886
• MDR Text Key: 280207021
• Report Number: MW5105085
• 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
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1