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

Model Number 6101

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

Information was received that the cadd prizm vip pump had error code 10037.No reported adverse effects.

Manufacturer Narrative

One cadd prizm pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint of error codes 10037 was verified.The event log did show the error code 10037.Service found the motor was intermittant.Service replaced the motor.Use testing was performed.The problem source is the faulty motor.

• 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: 8205333
• MDR Text Key: 131706483
• Report Number: 3012307300-2018-08930
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2018
• 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: 01/10/2019
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1