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 2016-11-11 for PYXIS ES manufactured by Bd / Carefusion.

Event Text Entries

[60349116] This is a second suboptimal design issue with pyxis es: scan alerts not recorded in history, scan transactions not able to be audited. Pyxis es allows you to require a scan transaction for drug loads and refills. However, it is not possible to pull a report of scan transactions (ndc scanned, alerts, number of scans). This prevents us from catching potential workarounds in the scan process. We had a recent near miss involving tranexamic acid. Tranexamic acid ivpbs are used in our ed for trauma pts and in our operating room for ortho pts. Since the administration for trauma pt is emergent, we have loaded tranexamic acid ivpb kits in the pyxis (vial + ns bag) that can be kept at room temp and are always available. For ortho, the need is not emergent and the orders are reviewed in advance. We prepare the ivpb in the iv room and load the appropriate quantity for the day in the pyxis refrigerator. The kit and the refrigerated ivpb have separate item numbers in pyxis and have different scan codes trained on them. An error where the kits were refilled into the refrigerated pocket in operating room was reported to us. Since we require a scan to refill into the pocket, we investigated how this could occur. The tech reported that she had taken the kits to the machine and had a scan failure, so she double-checked the drug (and it appeared correct) and inventoried the refrigerated pocket. She then pulled out one of the refrigerated ivpbs and scanned it to refill the kits into the pocket. This type of activity could potentially be identified in a complete audit trail. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066024
MDR Report Key6102225
Date Received2016-11-11
Date of Report2016-08-19
Date Added to Maude2016-11-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePYXIS ES
Generic NamePYXIS ES
Product CodeNZH
Date Received2016-11-11
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBD / CAREFUSION


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-11

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