MAUDE Adverse Event Report: PYXIS TECHNOLOGIES, INC. PYXIS; MEDICAL COMPUTER AND SOFTWARE

Model Number 4000

Device Problems Loss of Power (1475); Human Factors Issue (2948)

Patient Problem No Code Available (3191)

Event Date 09/26/2017

Event Type  No Answer Provided  

Event Description

A user attempting to place the pyxis machines in "critical override" mode inadvertently disabled all machines across the hospital.This was apparently very easy to do - with only a single prompt before the machines were completely disabled.All of the pyxis machines were inaccessible for about 24 mins.The pt who is the subject of this report required midazolam for compliance with the ventilator, but this was delayed by about 10 mins while i was physically and run up to the nurse.While the pt waited they experienced reduced ventilator volumes, tachycardia, obvious discomfort, and there oxygen saturation began to fall from 100% to 95% before the midazolam arrived.This writer has learned this is the second such event this year where pyxis machines were completely disabled due to a product use error by someone who inadvertently disabled all machines.A simple "are you sure you want to do this" pop-up is not sufficient for such a permanent action that has the consequence of removing access to medications.

• Brand Name: PYXIS
• Type of Device: MEDICAL COMPUTER AND SOFTWARE
• Manufacturer (Section D): PYXIS TECHNOLOGIES, INC.; 45911 port st; MI 48170
• MDR Report Key: 7100747
• MDR Text Key: 94399976
• Report Number: MW5073834
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• 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: 09/26/2017

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: 4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 62