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

Model Number 6101

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Event Description

Information was received that the cadd prizm vip pump over infused.No reported adverse effects.

Manufacturer Narrative

Additional information: reporter confirmed the issue was detected during preventive maintenance testing and no patient was involved.

Manufacturer Narrative

One cadd prizm vip pump was returned for analysis.However, the device was received and serviced before it was known there was a complaint on the device.According to the service depot notes from 04-dec-2018, the customer's alleged issue of over delivery was confirmed.Service trimmed the expulsor to correct the reported problem.The root cause of the reported problem is unknown.

• 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: 7931530
• MDR Text Key: 122548532
• Report Number: 3012307300-2018-03934
• 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,Followup
• Report Date: 01/29/2019

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: 09/11/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 10/11/2018; 01/03/2019
• Supplement Dates FDA Received: 11/09/2018; 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1