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

Model Number 21-7349-24

Device Problem Priming Problem (4040)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  malfunction  

Event Description

While priming the epidural tubing on the pump (prior to connecting to the patient), i noticed it was taking a long time to prime the tubing.It normally takes ~5 cc to prime the tubing fully, and 10 cc had been primed and still there was no solution coming out of the end of the tubing.I inspected the tubing and it seemed to be making it to the micron filter and was not going past the filter.I removed the tubing, and using the same pump, re=primed another tubing set.This tubing set worked normally with the same pump and was fully primed after 5 cc, pointing to the tubing (not the pump) as the 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.; minneapolis MN 55442
• MDR Report Key: 12324758
• MDR Text Key: 266910283
• Report Number: MW5103241
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 4108577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other