MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-PRIZM VIP SYSTEM; PUMP, INFUSION, PCA

Model Number 6101

Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2018

Event Type  malfunction  

Event Description

Information was received that the cadd prizm vip pump failed the volume test (b)(4).No reported adverse effects.

Manufacturer Narrative

Additional information received on 13-dec-2018 that this event occurred during testing and there was no patient involvement.One cadd prizm vip pump was returned for analysis.Visual inspection performed, and product found to be in a good condition.Event history log review was performed and found no evidence of reported problem.The pump was visually inspected and found no damaged or crack.During investigation the pump passed psi testing.The customer's reported problem regarding delivery accuracy was able to be duplicated.During investigation three separate delivery accuracy tests were performed and at least one test was outside the pump's delivery accuracy manufacturing specifications.Service replaced the pump expulsor to correct the reported problem.The root cause of the issue is unknown.Based on these investigation results, no corrective actions will be taken at this time.

• Brand Name: CADD-PRIZM VIP SYSTEM
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8096998
• MDR Text Key: 128118458
• Report Number: 3012307300-2018-08355
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• PMA/PMN Number: K000842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6101
• Device Catalogue Number: 21-8821-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1