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

Model Number 2110

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

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

Event Date 01/17/2018

Event Type  malfunction  

Event Description

Patient was undergoing pca delivered pain management when pump alarmed reservoir volume is zero.The reservoir used on these pumps are dosed and delivered with 100ml medication.When clinician removed cassette form pump she noted reservoir almost full.Following establish workflow the rn contacted pharmacy to have contents measured.Remaining volume found in the reservoir was measured at approx.70ml with 5-10 ml remaining in reservoir cassette.Pump and cassette sent to biomedical engineering for analysis and reporting.Biomedical downloaded the event log from the pump and noted the time that the cassette was attached to the pump (04:51 am) and when the cassette was remove approx.9 hours later (1:59pm).Biomedical reviewed the event log for this time period and noted that the volume the pump delivered matched the pumps programming of 0.4mg/hr dosing and pca dose of 0.4m of 0.1mg/ml dilaudid-hp.The pump delivered 15 pca doses 6.0mg) and approx.3.6mg of drug to give a final volume of greater than 95 ml.Biomedical prepared pump for manufacturer evaluation and analysis.Biomedical will provide the mfg.With pump and cassette used in this delivery in order to test devices together.This is a re-occurring event involving this model pump at our facility.Manufacturer response for pump, infusion, pca, cadd solis (per site reporter): this is an ongoing occurrence with this pump model and we are currently working with mfg to resolve.

• Brand Name: CADD SOLIS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL MD, INC; 3350 granada avenue north; oakdale MN 55128
• MDR Report Key: 7214682
• MDR Text Key: 98115160
• Report Number: 7214682
• Device Sequence Number: 0
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• 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: 01/23/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, PAIN MEDICATION
• Patient Age: 37 YR