MAUDE Adverse Event Report: SMITHS MEDICAL, ASD INC. INF-SET CLEO 42" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Failure to Deliver (2338); Connection Problem (2900)

Patient Problems Headache (1880); Nausea (1970); Pain (1994)

Event Type  Injury  

Event Description

Patient will increasing every month now due to side effects.Md aware.Nausea, diarrhea, foot pain, headaches.Patient also report issue with cleo last week where it did not connect to site correctly and pump alarmed and delivery was stopped for 20 or 30 min.Patient was unsure if she was supposed to change cartridge in tha situation, so she changed cartridge and tubing.Reminded patient about on call rph.No other information available.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF-SET CLEO 42" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, ASD INC.
• MDR Report Key: 12107719
• MDR Text Key: 260074021
• Report Number: MW5102253
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1