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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL MD, INC CADD SOLIS; PUMP, INFUSION, PCA Back to Search Results
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.
 
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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 Key7214682
MDR Text Key98115160
Report Number7214682
Device Sequence Number0
Product Code MEA
Reporter Country CodeUS
Number of Events Reported1
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
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number2110
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/23/2018
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer01/23/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2018
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 Number1
Treatment
OTHER, PAIN MEDICATION
Patient Age37 YR
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