MAUDE Adverse Event Report: CAREFUSION PYXIS ANESTHESIA SYSTEM 4000

Model Number 338

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pyxis anesthesia system drawer malfunction which caused the machine to be inoperable and vital medications and anesthesia supplies were unavailable for pt care.One of the mini-drawers was activated to dispense immediately prior to pt arrival in cesarean section operating suite.Instead of dispensing only 1 pocket the entire drawer opened.The drawer was unable to be fully closed and this caused the machine to be inoperable.All other drawers which contained anesthetic, emergency medications and vital anesthesia supplies were locked.Fortunately this was an urgent and not an emergency case.However, if this was an emergency cesarean section or another type of emergency surgery, pt harm would have been possible due to a delay in treatment.

• Brand Name: PYXIS ANESTHESIA SYSTEM 4000
• Type of Device: PYXIS ANESTHESIA SYSTEM 4000
• Manufacturer (Section D): CAREFUSION; san diego CA 92130
• MDR Report Key: 5553763
• MDR Text Key: 42435611
• Report Number: MW5061518
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 338
• Was Device Available for Evaluation?: Yes
• 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