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

Catalog Number 21-8821-01

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 10040 and 10106.No reported adverse effects.

Manufacturer Narrative

One cadd-prizm® vip ambulatory infusion pump was returned for analysis.The device was visually inspected and found a missing rear label, battery door and the pump was not able to power on.The reported event of error codes 10040 and 10106 was verified.It was determined that the rtc battery had a low battery voltage.A low voltage can cause error code 10040 and 10106.The rtc battery will be replaced to resolve the issue.

• 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: 8192505
• MDR Text Key: 131309940
• Report Number: 3012307300-2018-08873
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-8821-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1