MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CADDS SOLIS IV PUMP

Model Number 21-2101

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 09/11/2016

Event Type  malfunction  

Event Description

The patient had 2 cadd solis iv pumps in his home for tpn delivery.Two days in a row, both pumps have over infused tpn until bag ran dry.The bag ran dry 30 minutes prior to dosing schedule was set to complete.This caused an over-infusion of 100 ml of tpn fluid (which is outside of his ordered amount from physician) and infused 30 minutes faster than intended (23.5 hours instead of 24 hours), which caused about 55 mls to be infused into patient faster than order and without a ramp down.Patient has blood glucose issues, so not having a ramp down time could potentially cause an adverse event to occur.Since both pumps in home had over-infused, patient was forced to hook up to defective pump tubing for the next tpn infusion waiting for a new pump.Pumps were sent out to the home to replace the defective pumps and we will be getting the defective pumps back by thursday, 09/15/2016 or friday, 09/16/2016.Once they are back at our office, they will be sent to smiths medical.With patient's high volume for his tpn, the pump did not technically go outside the plus or minus 6 percent error rate that manufacturer states, but the pump delivered all of the formula too fast and 100 mls extra, which has not happened prior to these infusions.

• Brand Name: CADDS SOLIS IV PUMP
• Type of Device: IV PUMP
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; st. paul MN 55112
• MDR Report Key: 5955825
• MDR Text Key: 55122385
• Report Number: MW5064799
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR