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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH'S MEDICAL CADD SOLIS SMART PUMP; PCA SMART PUMP

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SMITH'S MEDICAL CADD SOLIS SMART PUMP; PCA SMART PUMP Back to Search Results
Device Problem Incorrect Software Programming Calculations (1495)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Other  
Event Description
Our institution has recently seen a rise in the patient controlled analgesia (pca) errors involving the cadd solis smart pump that reach patients despite a nursing independent double check.Upon investigating our institution's 2014 pca errors, the most common types of errors and the most likely to reach patients and cause harm were programming errors, one of which involves concentration changes.A pca double check is currently in place at our institution to ensure the correct drug, concentration and dose is programmed into the pump for each patient.The first nurse programs the pump with the pain management pathway (opioid naive vs tolerant with set hard and soft limits programmed into the pca pump library), drug, concentration and patient- specific dosing parameters (continuous rate, pca dose, pca lockout and one hour limit).After programming the pca pump, a double check of the settings is performed by a second nurse.The smart pump cadd solis display prompts the double checker to review the patient-specific dosing parameters.As each parameter is reviewed and verified by the second nurse, a check mark appears next to that parameter.The pump does not prompt the second nurse to double check and verify the pain management pathway specifically the drug named and concentration.Although our independent double check process outlines the need to check the drug name and concentration, because the pump program prompts the nurse to check all the settings except the drug name and concentration, it is an "easier" mistake to make.Additionally, after changing out a cassette, the pump does not prompt the nurse to ensure the recheck any settings.After insertion of a new cassette, the pump only prompts the nurse to ensure the cassette is locked and to prime the tubing.This also leaves room for error if there is a drug or concentration change.While there are many contributing factors that can result in smart pump errors, this is one that was brought to our attention by nursing staff.We contacted smiths medical, the manufacturer of cadd solis pca, with a request to update the software to force the user to double check the drug name and concentration and to require re-verification of the dosing parameters with each cassette change.Smiths medical denied the request stating that modifications could not be made since the information was hard coded and that the use of a double check system should be what is used to ensure this information is accurate.We are in agreement that an independent double check will help ensure accuracy; however, we have two concerns with the lack of a prompt to double check the drug and concentration.Firstly, it provides a false sense of security for nurses because all other functions on the pump request a double check.Secondly, it has made it difficult to error proof our workflow as the user can move forward in the pump programming process without a double check.Please refer to the images provided.Figure 1: this figure shows the start of the double check process, with the first parameter of "continuous rate," having been verified by the second nurse as indicated by the check mark to the left.The top portion of the screen in purple provides the drug and concentration.No double check of this information is required.Figure 2: this figure shows the screen once the four parameters are double checked.Again, no double check of the drug and concentration is required.Figure 3: this is the first screen the user sees upon reinsertion of a cassette.The smart pump does not prompt the user to re-verify the drug name/concentration/ and pca settings.Per our policy and procedure every pca cassette change requires a double check.Medication administered to or used by the patient: no.(b)(6).(b)(4).
 
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Brand Name
CADD SOLIS SMART PUMP
Type of Device
PCA SMART PUMP
Manufacturer (Section D)
SMITH'S MEDICAL
MDR Report Key5406458
MDR Text Key37440361
Report NumberMW5059933
Device Sequence Number1
Product Code MEA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
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