From: Risacher, Wendi Sent: Monday, April 13, :01 AM To: Hupp, Diane Subject: Corrected Alaris safety concerns. Hi Diane,

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2 From: Risacher, Wendi Sent: Monday, April 13, :01 AM To: Hupp, Diane Subject: Corrected Alaris safety concerns Hi Diane, I just again wanted to thank you for personally coming to address the Alaris pump issues and support the nursing staff. I am forwarding the list of concerns that the senior staff (Myself, Chris Madden. Karla Persia, Nicole Gargarella, Diane Hake, Brittany Tatro, Deanna Schneider, Mike Badach, Dawn Badach, Annette Fleck) compiled. I am not sure if you had ever seen the list so I just wanted to make sure that you had it. Most of the issues are product design and are not fixable. Your personal presence yesterday was appreciated by the staff. Thanks Wendi Risacher

3 Alaris Syringe Pump Concerns/Childrens PICU/CICU 1. Vital information is not displayed in one area. Need to navigate thru many screens to check dose, wgt. concentration. Too many steps to verify in an emergency. Old pumps had all info in one easy place with the syringe directly above in a horizontal manner so that you could compare the syringe to the pump. Even with the very easy to operate Medfusion pump, PSORS happened often with programming or placing wrong syringe on pump. 2. The most vital info (the dose) is not displayed constantly across the screen. Have to stand and watch it scroll to verify dose. Also have to bend over and read syringe vertically. The second row of pumps are practically on the floor and are difficult to see. 3. Unable to turn syringe in pump to read all details on label without syringes coming out and having to reprogram pump. Also pt gets bolused or decompensates with syringe manipulation. 4. There is no back button to the previous screen if you make an error. You must shut the channel down and start over. 5. Can't reprogram new concentration of infusion without shutting pump down. No option to just alter concentration. 6. Can not infuse fluid bolus on pump if programmed correctly for most patients. Get max volume error that can't be overridden. 7. The already addressed dose wt changing error potential. 8. Will allow you to choose the wrong syringe size. Accepted my choice of a 1cc when a 3cc was inserted. Had to shut whole channel off and start over instead of just changing it. 9. Med chambers have no independent battery. If something happens to main brain, all pressors will shut off. 10. Many more steps and buttons to push to do same tasks. We compared programming a dose of Vanco on both pumps and the Alaris took 14 steps/button pushes and 69 seconds vs the Medfusion 9 steps/button pushes and 39 seconds. we both did it at a normal pace, not racing. 11. Pumps constantly alarming disturbing patients and families. Very frustrating to nurses. Alarm silence time different for different things. Some only last 10 seconds for syringes/tubing changes. It is very distracting when you are changing life saving medication and we are focusing on stopping the alarms instead of our task at hand. Even when you put it on delay, when you take the syringe out it starts re-alarming. 12. You can not tell which pump is alarming. Nurses are telling me that they are very anxious when they have sick patients on pressors every time the pumps ring. 13. Medications take longer to infuse because it will only let you infuse the amount that is in the syringe after priming the tubing...not the whole dose. We already often run out of access when giving multiple medications. This leads to delays in getting meds into patient. Can interfere with peak and troughs. 14. Won't let you program total dose of med when it is greater than 60cc to run at your rate. Electrolytes come in a bag but must be infused via mini pump. We use a push pull system with a 60cc syringe but program 100cc to run over 2 hours. Old pump would allow this and just alarm when syringe was empty and we would refill syringe from the bag to complete the infusion.

4 15. I have witnessed many nurses just pushing the remaining volume of med in their tubing instead of infusing the flush because the pumps are so difficult. 16. On intermittent meds in 3,5,10cc syringes, you have to program both the dose and volume. You can't program the pump without the syringe in...but with the syringe in, you cant see both the dose and volume so you have to turn it or take it out...both of which make you start over from the beginning. If you type the wrong info in by accident, you have to shut it off and start all over again. With our other pumps we just programmed the med concentration, which was programmed in pump, and the dose. The volume was already figured out by the pump. 17. The physicality of the pumps are also unacceptable for both nursing and families. When they are at the head of the bed, we can not not reach our emergency resuscitation equipment (mapelson bag, suction, trachs, face masks.). We also need many more poles to use the same amt of pumps that we used to have one pole for. When the patients lines are on the L side of the bed, the parents can not get to their child or even see their child from the couch. The parents then have to come on the R side of the bed to see their child which is interfering with our ability to provide care leading to both parental and nursing frustration. 18. Transporting patients now takes extra hands to push multiple poles, and maneuvering through doorways/hallways is difficult. Pumps stick out and get knocked off of bed and walls leading to potential chamber disruption and purging of medication. They are also unstable risking accidental line removal. 19. Pumps stick out too far and tubing on far end of pump has very little slack leading to increased risk of accidental line removal. Parents often accidentally bump pumps and are afraid of harming their child. I had a parent come out of her room terrified because she tripped and bumped the pumps. 20. Old pumps showed volume infused on screen to know when specific volume reached the patient (Cris Madden brought this up and can speak to this issue better than I). 21. Nurse had to add second chamber to her pump and her Epi pump became dislodged on unstable patient. 22. Can't remove inner chambers if pt not using them when outer chambers are infusing meds. When other nurses need pumps we have many unused that we can not give them without interrupting our own patient's meds to remove chambers. 23. Old mini pumps were easy to transport by placing on patients bed. Alaris unable to do this. 24. Too bulky for CT and MRI. Tubing on outer chamber too short. 25. After checking main brain for med dose/concentration/wt we have to hit start or the pump will alarm making it seem as if the pump stopped working. Why do we have to hit start if we didn't stop it? Just more extra steps and nuisance alarms. 26. Plunger is sensitive and it is hard to place it without bolusing the med, or placing it on too loose so that the lag time is greater. 27. Takes way too long to change syringe on critical infusions. Several nurses have stated that they felt that their patient would have random abnormal blood pressure swings even when they did nothing to the pump. Even if we "double run" our pressors, we do not do this process with the flush or other meds in the same line so now those changes will affect the pt as well.

5 28. Nurses are programming their pumps in the basic infusion mode (which bypasses all of the safety features of the pump) because the program is too difficult/time consuming/frustrating to use. 29. Free flow risk is much greater with a vertical syringe style vs horizontal. Problems that should be easy to fix 1. Can near empty alarm be dc'd? 2. No option to piggyback meds when programmed in TPN mode. 3. Many meds not found in library. 4. Reference cards on pumps get in the way of the chambers attaching, and are in infections hazard. I stayed after work to do this so sorry it there are any grammar/typing errors. Wendi

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