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

Catalog Number 21-8821-82

Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)

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

Event Date 08/31/2018

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 high pressure alarm and cassette damaged alarm not verified.Event log shows high pressure alarm occurred (b)(6) 2018.Service will replace the downstream occlusion sensor as a precaution.Fluid ingression was found on the downstream sensor during visual inspection.Use testing was performed.The problem source is unknown.

Event Description

Information was received that the cadd prizm vip pump has high pressure alarm and cassette damaged alarm.No reported adverse effects.

Manufacturer Narrative

Additional information was received indicating this observation was found during testing.There was no patient involvement.One pump was returned for analysis in used condition.Visual inspection of the pump showed that the pump was in good physical condition.Review of the pump event log noted a high pressure alarm was recorded.Functional testing included occlusion testing.The pump's downstream sensor was in specification when performing a occlusion test.Fluid ingression was found on the downstream sensor during further visual inspection.The downstream occlusion sensor was replaced as a preventative measure.Based on the evidence, the complaint was unable to be confirmed.

• 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: 7939997
• MDR Text Key: 122877508
• Report Number: 3012307300-2018-03951
• 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: 11/13/2018

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 Catalogue Number: 21-8821-82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1