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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

One cadd pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint of overinfusion was not verified.Event log shows no alarms.Service did not replaced any items.Delivery accuracy testing passed.Use testing was performed.The problem source is unknown.

Event Description

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

Manufacturer Narrative

Additional information received.Event date updated.

• 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: 7931539
• MDR Text Key: 122547810
• Report Number: 3012307300-2018-03933
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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: 08/31/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1