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

Model Number 2110

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Pain (1994)

Event Date 08/22/2015

Event Type  malfunction  

Event Description

Pt's pca pump was malfunctioning, and pt was not receiving medication from approx.11:30 to 1430.Pca pump replaced and rn is closely monitoring to make sure pt is receiving medication per order.Pca was started at 1000 and delivery log shows 3 delivered doses till 13:30, and screen continued to say "running" until 1630, when it alarmed that "pca cord was not connected." while a dose was not delivered, the machine still registered an "attempt." rn pushed cord back in and pt hit pca pump and received a dose.Pca pump was replaced, and taken out of service.The pt was frequently assessed and assisted to bathroom throughout the gap in pain medication; and pt reported pain was manageable and she felt better each time she ambulated.Rn noted low number of doses given and discussed increasing use with patient to better manage pain.Pt reported she was "trying to not overdo it." placed an abdominal binder to help with abdominal pain, and are monitoring pca pump and will continue assess pain.Will notify oncoming nurse, and put in an occurrence report.The time log on the pca pump was off by 2 hours.Pca was started at 1200, final dose was given at 1700, and pump was replaced immediately afterwards.

• Brand Name: CADD SOLIS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene, NH 03431
• MDR Report Key: 5110609
• MDR Text Key: 27019185
• Report Number: 5110609
• 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: User Facility
• Reporter Occupation: Other
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2110
• Other Device ID Number: 2542B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 58