MAUDE Adverse Event Report: CAREFUSION PYXIS ES; MEDICATION DISPENSING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/20/2016

Event Type  malfunction  

Event Description

Issue with pyxis es machine failing drawers leaving medications and emergency supplies unavailable.A scheduled monthly generator load test took place on 04/20/2016 at 0500.Backup batteries were previously installed (04/19/2016) onto each pyxis es machine in the hospital in anticipation of the load test.Upon utility interruption, two pyxis es machines located in labor and delivery (pyxis es machine wmc ld2) and nicu (pyxis es machine (b)(6) nicu2) experienced multiple drawer failure.Additional individual pocket failures were experienced in critical care 2, critical care 3, observation unit, emergency room east, and emergency room north.A total of 390 drawers failed seconds after the utility interruption occurred.The majority of the failures were experienced in labor and delivery and nicu.

• Brand Name: PYXIS ES
• Type of Device: MEDICATION DISPENSING
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 5640725
• MDR Text Key: 44791697
• Report Number: MW5062141
• Device Sequence Number: 2
• Product Code: JQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/05/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other