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

Model Number 6101

Device Problems Occlusion Within Device (1423); Pressure Problem (3012)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

One smiths medical cadd-prizm® vip system was returned for analysis in good condition.The event history log was reviewed and noted that the high pressure alarm messaged after start up.The pressure switch test was found to be activated low which is out of the pump's manufacturer specifications.Visually inspected the pump and found it had fluid ingression.Based on the evidence, the "occlusion pressure low" issue was caused by fluid ingression; result of use of the device inconsistently with the instructions for use (ifu).

Event Description

Information was received indicating that a low occlusion pressure alarm occurred to a smiths medical cadd-prizm® vip system.There were 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 n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7324904
• MDR Text Key: 101920148
• Report Number: 3012307300-2018-00510
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

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: 01/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1