MAUDE Adverse Event Report: SMITHS MEDICAL SMITHS CADD BLUE STRIPE ADMINISTRATION SET 7036

Model Number 21-7036-01

Device Problem Air Leak (1008)

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

Event Date 01/28/2017

Event Type  Injury  

Event Description

Patient was undergoing home treatment with vip ambulatory pump and blue stripe admission set.Air bubbles were observed in the lines between the filter and the patient.The patient had to return to the clinic and have set changed.This is not the first time that clinician has observed that (other patients, same pump model and sets).Last year we tested a dozen or more various smiths sets and observed air in the lines - with smiths engineers present as well.We are still waiting for the investigation results, root cause analysis, and corrective action outcomes for those sets.

• Brand Name: SMITHS CADD BLUE STRIPE ADMINISTRATION SET 7036
• Type of Device: SMITHS CADD BLUE STRIPE ADMINISTRATION SET 7036
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• MDR Report Key: 6308324
• MDR Text Key: 66809625
• Report Number: MW5067717
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: CA
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7036-01
• Device Lot Number: 46X858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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