FDA Adverse Event Other Summary report: N

ALARIS PUMP

MDR report key: 2854922 · Received November 29, 2012

Report

Report Number
MW5027801
Event Type
Other
Date Received
November 29, 2012
Manufacturer
CAREFUSION 303, INC
Product Code
FRN
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

(B)(6). DATE RECEIVED: (B)(4) 2012. ACTUAL ERROR: YES. DESCRIPTION: SITUATION: A FENTANYL INFUSION WAS ORDERED USING EPIC SOFTWARE FOR A (B)(6) PT AT A RATE OF 2 MCG/KG/HR, FOR A TOTAL OF 30 MCG/HR. THE ALARIS PUMP USED TO ADMINISTER THE INFUSION DID NOT HAVE AN OPTION TO SELECT 30 MCG/HR. THE PUMP WAS THEN INADVERTENTLY PROGRAMMED TO ADMINISTER 30 MCG/KG/HR. BACKGROUND: FENTANYL IS A STRONG AGONIST AT MU-OPIOID RECEPTORS, WITH A RELATIVELY RAPID ONSET AND SHORT DURATION OF ACTION. INTRAVENOUS FENTANYL IS COMMONLY USED FOR ANALGESIA AND FOR ANESTHESIA, OFTEN IN COMBINATION WITH A BENZODIAZEPINE. AS A POTENT OPIOID AGONIST, ITS SIDE EFFECTS CAN BE POTENTIALLY FATAL, ESPECIALLY IF ADMINISTERED AT HIGH, INAPPROPRIATE DOSES. IN PARTICULAR, THESE SIDE EFFECTS INCLUDE SOMNOLENCE, RESPIRATORY DEPRESSION, SEIZURES, AND COMA. CONTINUOUS SEDATION OR ANALGESIA WITH FENTANYL FOR PEDIATRIC PATIENT IS RECOMMENDED WITH AN INITIAL IV BOLUS OF 1-2 MCG/KG AND THEN 1 MCG/KG/HR. TITRATION TO DESIRED EFFECT IS APPROPRIATE WITH USUAL DOSING AT 1-3 MCG/KG/HR, THOUGH SOME PTS REQUIRE 5 MCG/KG/HR. ASSESSMENT: A MEDICATION ERROR OCCURRED IN OUR HOSPITAL AND WAS RECORDED AS A NEAR MISS MEDICATION EVENT IN OUR VOLUNTARY ONLINE REPORTING SYSTEM, QUANTROS. THIS ERROR COULD HAVE RESULTED IN A PEDIATRIC PT RECEIVING AN OVERDOSE OF MEDICATION (FENTANYL INFUSION), POTENTIALLY RESULTING IN SEVERE HARM HAD THE ERROR NOT BEEN DISCOVERED PRIOR TO ADMINISTRATION. THE MEDICATION SAFETY OFFICER BECAME AWARE OF THE SITUATION AFTER REVIEWING QUANTROS REPORTS AND FURTHER EVALUATED THE OPTIONS FOR ORDERING PEDIATRIC INFUSION IN THE EPIC SYSTEM. IT WAS FOUND THAT THE UNITS AVAILABLE TO SELECT WHEN ORDERING A MEDICATION DID NOT MATCH THE UNITS AVAILABLE TO SELECT FOR ADMINISTRATION OF THE MEDICATION VIA ALARIS PUMPS FOR ALL PEDIATRIC INFUSIONS. AT THE TIME OF THE ERROR, PROVIDERS COULD NOT APPROPRIATELY ORDER FENTANYL INFUSIONS (AND CERTAIN OTHER MEDICATIONS) FOR PEDIATRICS. THESE INFUSIONS COULD ONLY BE ORDERED IN MCG/HR OR ML/HR, HOWEVER, THEY SHOULD BE ORDERED IN MCG/KG/HR (PER THE JOINT COMMISSION AND TO COMPLY WITH GUARDRAILS ON ALARIS PUMPS). ALARIS PUMPS USED TO ADMINISTER THESE INFUSION TO PTS ARE PROGRAMMED WITH THE UNITS, MCG/KG/HR. IN THIS SITUATION, THE UNITS FOR FENTANYL DID NOT CORRESPOND BETWEEN THE ALARIS PUMP AND THE EPIC SYSTEM, SO THE PUMP WOULD NOT ALLOW THE DOSE TO BE SELECTED AS ORDERED IN EPIC. SINCE THE DOSE OF 30 MCG/HR WAS NOT A PROGRAMMABLE OPTION, THE PUMP WAS INADVERTENTLY PROGRAMMED FOR 30 MCG/KG/HR. THE PT RECEIVED A BOLUS THAT WAS WITHIN NORMAL RANGE AND THE ERROR WAS DISCOVERED PRIOR TO ADMINISTERING THE INCORRECT INFUSION, THEREFORE, THE PT WAS NOT HARMED. RECOMMENDATION: UNITS SHOULD CORRESPOND BETWEEN THE EPIC SYSTEM AND ALARIS PUMPS TO PREVENT POTENTIAL MEDICATION ERRORS FROM OCCURRING. WITHOUT MATCHING UNITS, NURSES HAVE THE RESPONSIBILITY OF CONVERTING THE DOSES TO APPROPRIATE UNITS, WHICH CAN RESULT IN A DELAY OF MEDICATION ADMINISTRATION AND A MEDICATION ERROR DUE TO MISCALCULATION, OR INAPPROPRIATE DOSING UNITS MAY BE SELECTED, WHICH COULD CAUSE SERIOUS HARM TO PTS. THE UNITS DISPLAYED ON ALARIS PUMPS CANNOT BE ALTERED, SO THE EPIC SYSTEM REQUIRES MODIFICATION. THE OPTIONS AVAILABLE TO SELECT UNITS FOR MEDICATIONS SHOULD BE MODIFIED IN THE EPIC SYSTEM SO THAT THEY MATCH THE ALARIS PUMPS. THESE UNITS SHOULD BE ADDED AS AN OPTION AS A DROP-DOWN BOX FROM THE MAGNIFYING GLASS ICON. HIGHLIGHTING THE UNITS AVAILABLE ON THE ALARIS PUMPS IN EPIC MAY ALSO HELP MAKE PRESCRIBERS AWARE THAT THOSE ARE THE ONES THAT CORRESPOND TO THE PUMPS. NURSES AND PROVIDERS SHOULD BE EDUCATED ABOUT THIS NEAR MISS MEDICATION ERROR, AS WELL OF THE NEW FEATURES THAT WILL BE IMPLEMENTED INTO THE SYSTEM. IF ANY MEDICATION IS MISSED AND THIS SITUATION SHOULD BE IMPLEMENTED. THE PHARMACY SHOULD BE EQUIPPED WITH TOOLS AND CONVERSION CHARTS TO ASSIST WITH UNIT AND DOSE CONVERSIONS THAT MAY BE COMMONLY USED. WHENEVER THIS PROCEDURE OCCURS, A BRIEF EXPLANATION OF THE STEPS TAKEN TO ENSURE CORRECT DOSAGE ADMINISTRATION SHOULD BE DOCUMENTED. THESE INDIVIDUAL CASES SHOULD BE REPORTED TO THE MEDICATION SAFETY OFFICER WHO SHOULD F/U WITH THE MAKING ADD'L CHANGES IN THE EPIC SYSTEM AS NECESSARY. MEDICATION ADMINISTERED TO OR USED BY THE PT: NO. OUTCOME: THE PT WAS NOT HARMED. WHEN AND HOW WAS ERROR DISCOVERED: THE PT RECEIVED A BOLUS THAT WAS WITHIN RANGE AND THE ERROR WAS DISCOVERED PRIOR TO ADMINISTERING THE INCORRECT INFUSION, THEREFORE, THE PT WAS NOT HARMED. PT COUNSELING PROVIDED: UNK. REPORTER'S RECOMMENDATION: UNITS SHOULD CORRESPOND BETWEEN THE EPIC SYSTEM AND ALARIS PUMPS TO PREVENT POTENTIAL MEDICATION ERRORS FROM OCCURRING. WITHOUT MATCHING UNITS, NURSES HAVE THE RESPONSIBILITY OF CONVERTING THE DOSES TO APPROPRIATE UNITS, WHICH CAN RESULT IN A DELAY OF MEDICATION ADMINISTRATION AND A MEDICATION ERROR DUE TO MISCALCULATION, OR INAPPROPRIATE DOSING UNITS MAY BE SELECTED, WHICH COULD CAUSE SERIOUS HARM TO PTS. THE UNITS DISPLAYED ON ALARIS PUMPS CANNOT BE ALTERED, SO THE EPIC SYSTEM REQUIRES MODIFICATION. THE OPTIONS AVAILABLE TO SELECT UNITS FOR MEDICATIONS SHOULD BE MODIFIED IN THE EPIC SYSTEM SO THAT THEY MATCH THE ALARIS PUMPS. THESE UNITS SHOULD BE ADDED AS AN OPTION AS A DROP-DOWN BOX FROM THE MAGNIFYING GLASS ICON. HIGHLIGHTING THE UNITS AVAILABLE ON THE ALARIS PUMPS IN EPIC MAY ALSO HELP MAKE PRESCRIBES AWARE THAT THOSE ARE THE ONES THAT CORRESPOND TO THE PUMP. NURSES AND PROVIDERS SHOULD BE EDUCATED ABOUT THIS NEAR MISS MEDICATION ERROR, AS WELL OF THE NEW FEATURES THAT WILL BE IMPLEMENTED INTO THE SYSTEM. IF ANY MEDICATION IS MISSED AND THIS SITUATION COMES UP AGAIN, A PROCEDURE OF HAVING THE NURSE CHECK WITH A PHARMACIST TO VERIFY THE UNIT CONVERSION SHOULD BE IMPLEMENTED. THE PHARMACY SHOULD BE EQUIPPED WITH TOOLS AND CONVERSION CHARTS TO ASSIST WITH UNIT AND DOSE CONVERSIONS THAT MAY BE COMMONLY USED. WHENEVER THIS PROCEDURE OCCURS, A BRIEF EXPLANATION OF THE STEPS TAKEN TO ENSURE CORRECT DOSAGE ADMINISTRATION SHOULD BE DOCUMENTED. THESE INDIVIDUAL CASES SHOULD BE REPORTED TO THE MEDICATION SAFETY OFFICER WHO SHOULD F/U WITH MAKING ADD'L CHANGES IN THE EPIC SYSTEM AS NECESSARY. RELEVANT MATERIALS PROVIDED: NONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ALARIS PUMP PUMP FRN CAREFUSION 303, INC
2 EPIC SYSTEM SOFTWARE NSX EPIC

Patients

Seq Age Sex Outcome Treatment
1