MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problems Failure to Infuse (2340); Device Displays Incorrect Message (2591)

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

Event Date 10/15/2018

Event Type  malfunction  

Event Description

The cassette volume was set electronically on the pump at 100 ml and a "reservoir volume is zero" alarm alerted the nurse when it was electronically depleted roughly six hours later.The nurse found a physically full 100 ml cassette indicating no medication infused.The time range was roughly 6 hours from approximately 10:47 am until approximately 3:47 pm.The total amount infused during this period would have depleted the cassette based on the pca settings.The cassette was retrieved and it physically had 100+ ml in the cassette and the contents were assayed with a 98.75% result.The same pump was used previously with almost identical settings and the same medication for twelve hour infusions running at intervals of roughly six hours with no issues.

• Brand Name: CADD SOLIS PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• MDR Report Key: 8105416
• MDR Text Key: 128395804
• Report Number: 8105416
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2018,10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA