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

Model Number 2120

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

One cadd solis vip pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint was verified.The event log did show system fault 42,224 occurred.The circuit board will be replaced.Use testing was performed.The problem source is the circuit board.

Event Description

Information was received that the cadd prizm vip pump has error 42224.No reported adverse effects.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7891066
• MDR Text Key: 120828410
• Report Number: 3012307300-2018-03669
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517084368
• UDI-Public: 15019517084368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

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: 2120
• Device Catalogue Number: 21-2120-0103-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1