MAUDE Adverse Event Report: CADD SOLIS

Device Problems Inadequate Instructions for Healthcare Professional (1319); Programming Issue (3014)

Patient Problem Overdose (1988)

Event Type  Other  

Event Description

We have had errors with programming our pca pump which has resulted in pts receiving either a 5x (morphine) or 10x (hydromorphone) overdose (4 in the last 6 months).All of these cases involve a change from a standard (lower) concentration to a max (higher) concentration.In these cases, despite the nurse knowing that there is a change in the order, the pump was not been updated.In most of these cases, the error was found during a handoff between on-coming care providers.A contributing factor we've identified is the design layout of the pump programming screen.When programming the pump (cadd solis), the drug and concentration are picked together (i.E.Morphine at a concentration of 1 mg/ml is picked as morphine 1 mg/ml; the concentration is not picked separately).Once selected, the nurse is brought to a screen where the pca dose, continuous rate, 4 hour max dose, and lockout interval are input.The pump requires that the user confirm these settings before starting.In the cases we have seen, there usually is not a change in these parameters, only the concentration.Because everything else is the same, concentration is inadvertently omitted as a part of the independent double check.Additionally, the concentration display is on the far right side of the pump.When discussing these cases with staff involved, they frequently have commented that their focus is drawn to the dosing questions and not to the concentration.We feel the pump mfr can do a better job distinguishing the drug's concentration, perhaps including this as one of the items listed in the "clipboard" area on the programming screen.Finally, another contributing factor is that there is not a requirement to re-check your drug/concentration when a cassette is detached and a new one reattached.There are obvious advantages to this (not having to reprogram every time the cassette runs out), this negatively impacts changing to a new drug concentration.It is worth noting that our practices of independent double check have drifted from a truly independent check to more of a team based check.In discussions on why this is we have focused on our shift from a paper based check list, to an electronic one.The computers in the room are on the opposite side of the room from the pt's bed, making it difficult to independently verify the pump programming and the drug order.Some of our nurses have resorted to taking a picture of the pump and bringing it with them to the computer to compare.Please let me known any questions you may have.I think this has highlighted several important safety issues for use: human factors design of medication -related devices, implementation of risk reduction strategies (independent double checks) based on workspace layout coupled with transition to a fully electronic documentation system.(b)(6).

• Brand Name: CADD SOLIS
• Type of Device: CADD SOLIS
• MDR Report Key: 4883806
• MDR Text Key: 6265620
• Report Number: MW5043388
• Device Sequence Number: 1
• Product Code: MEA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2015
• Patient Sequence Number: 1