PYXIS ES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-19 for PYXIS ES manufactured by Carefusion (bd).

Event Text Entries

[43657002] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5061826
MDR Report Key5597601
Date Received2016-04-19
Date of Report2016-04-19
Date of Event2016-04-19
Date Added to Maude2016-04-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePYXIS ES
Generic NamePYXIS ES
Product CodeMMH
Date Received2016-04-19
Model NumberPYXIS ES
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION (BD)
Manufacturer AddressSAN DIEGO CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-04-19

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