MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7349-24

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Epidural spiked and tubing placed into cadd pump.Tubing would not click into cadd pump easily.When tubing was able to click in and attempted to prime, pump alarmed "upstream occlusion".Tubing was removed and new tubing was opened.New tubing attached to pump and primed/running without issue.Fda safety report id # (b)(4).

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14676854
• MDR Text Key: 294030606
• Report Number: MW5110275
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7349-24
• Device Lot Number: 4230893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose