MAUDE Adverse Event Report: BD / CAREFUSION PYXIS ES

Device Problems Application Program Problem (2880); Data Problem (3196); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

This is a second suboptimal design issue with pyxis es: scan alerts not recorded in history, scan transactions not able to be audited.Pyxis es allows you to require a scan transaction for drug loads and refills.However, it is not possible to pull a report of scan transactions (ndc scanned, alerts, number of scans).This prevents us from catching potential workarounds in the scan process.We had a recent near miss involving tranexamic acid.Tranexamic acid ivpbs are used in our ed for trauma pts and in our operating room for ortho pts.Since the administration for trauma pt is emergent, we have loaded tranexamic acid ivpb kits in the pyxis (vial + ns bag) that can be kept at room temp and are always available.For ortho, the need is not emergent and the orders are reviewed in advance.We prepare the ivpb in the iv room and load the appropriate quantity for the day in the pyxis refrigerator.The kit and the refrigerated ivpb have separate item numbers in pyxis and have different scan codes trained on them.An error where the kits were refilled into the refrigerated pocket in operating room was reported to us.Since we require a scan to refill into the pocket, we investigated how this could occur.The tech reported that she had taken the kits to the machine and had a scan failure, so she double-checked the drug (and it appeared correct) and inventoried the refrigerated pocket.She then pulled out one of the refrigerated ivpbs and scanned it to refill the kits into the pocket.This type of activity could potentially be identified in a complete audit trail.(b)(4).

• Brand Name: PYXIS ES
• Type of Device: PYXIS ES
• Manufacturer (Section D): BD / CAREFUSION
• MDR Report Key: 6102225
• MDR Text Key: 60349116
• Report Number: MW5066024
• Device Sequence Number: 1
• Product Code: NZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• 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 Number: 1