MAUDE Adverse Event Report: CAREFUSION (BD) PYXIS ES

Model Number PYXIS ES

Device Problems Computer Software Problem (1112); No Device Output (1435); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/19/2016

Event Type  malfunction  

Event Description

The pyxis es platform provides control of all the pyxis medstations (automated medication dispensing systems).The pyxis es platform (version 1.3.4) has major communication problems with the medstations and this regularly results in complete service outages for extended periods of time.When this outage occurs, all the medstations for the entire organization lose their communication link with the pyxis es platform.The 300+ medstations then have to be manually placed on override.Medication orders, admit/transfer/discharge orders from the emr do not propagate to the intended destination.The pt safety measures put in place are basically rendered useless during the outages.The most recent complete system-wide outage occurred today.The frequency of complete system-wide outages is about 5 to 6 times a month.The duration of the complete system-wide outage varies anywhere between one hour to 8+ hours.In the 8 months since we upgraded to the pyxis es system, there have been more than 30 instances of complete system-wide outages.In addition to the complete system-side outages, there have been several instances of service interruptions that have impacted pt safety and pt care.Carefusion has not been able to identify the root cause of the problem, and has been actively investigating this issue for the past 8 months.They have offered up an upgrade to another version 1.4.4.1 as a potential fix.However, this software has yet to be released, with the release date being constantly pushed back.Additionally, carefusion has offered up the upgrade to 1.4.4.1 as a "test release version", and has not set a date for the production version release.Since carefusion has yet to identify what is causing the issues in version 1.3.4, it is unclear as to how a different version would resolve the connectivity/stability problems.

• Brand Name: PYXIS ES
• Type of Device: PYXIS ES
• Manufacturer (Section D): CAREFUSION (BD); san diego CA
• MDR Report Key: 5597601
• MDR Text Key: 43657002
• Report Number: MW5061826
• Device Sequence Number: 1
• Product Code: MMH
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PYXIS ES
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other