MAUDE Adverse Event Report: CAREFUSION CAREFUSION PYXIS MACHINE; PYXIS ANESTHESIA 400

Model Number PYXIS

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 02/10/2015

Event Type  Injury  

Event Description

Periodically without warning the pyxis anesthesia system is locking up giving the anesthesiologist a drawer 2-1 failure message.The machine is no longer accessible when this happens.In order to clear the problem the machine must be turned off and back on again.This issue has occurred several times on different machines throughout the operating area and birthing operating room with the worst situation having happened when anesthesia was setting up fro an emergency c-section.The anesthesiologist quickly trying to prepare for the case had the pyxis a-system lock up with a drawer 2-1 failure.Pharmacy responded immediately but had to garb up before going into the room which took time for them to get the machine operational.Our mitigation strategy is we have anesthesia trays available for anesthesia to use if the machines do not work.These trays are available in the operating room as well as the birthing area and have everything anesthesia needs to safely run a case.

• Brand Name: CAREFUSION PYXIS MACHINE
• Type of Device: PYXIS ANESTHESIA 400
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 4531426
• MDR Text Key: 5358563
• Report Number: MW5040790
• Device Sequence Number: 1
• Product Code: JQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PYXIS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR