MAUDE Adverse Event Report: EPIC SYSTEMS CORP. EPIC; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

Our health system uses pyxis es and pyxis logistics as our automated dispensing cabinet and inventory management system respectively.Early in "xxx" it was identified that some of the bar code scan codes for epic vs.Logistics vs.Pyxis es did not match.The original error was with different doses of misoprostol.No incorrect doses reached patients, but it was identified that when a scan code is changed in logistics it does not always change in es depending on the way the original input was created although the clear impression was that these two systems are linked.The scan code change sent to es when changed in logistics is rejected under certain circumstances but no error message is created for the user to know that there is now a disconnect.Retrospective review identified dozens of other examples including iv iron linked to rosuvastatin and ambrisentan linked to oral ferrous sulfate despite these being corrected in the logistics system in the past.Other examples include preservative free and non preservative free items incorrectly linked.Exhaustive review of use showed no incorrect administrations evident bd has been working with our pharmacy group for investigations but it is there assertion that the systems are working as designed.No training material or intro materials available demonstrate that scan codes need to be changed simultaneously in two systems.Our concerns are that other organizations may fall into this same pitfall and may be at risk of incorrect stocking/administration.We hope to get more communication out there about this system fault.(b)(4).

• Brand Name: EPIC
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): EPIC SYSTEMS CORP.
• MDR Report Key: 15079373
• MDR Text Key: 296415012
• Report Number: MW5111039
• Device Sequence Number: 3
• Product Code: MMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/20/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN ; FERROUS SULFATE ; MISOPROSTOL ; ROSUVASTATIN CALCIUM