MAUDE Adverse Event Report: CAREFUSION PYXIS ANESTHESIA SYSTEM (PAS); AUTOMATED DISPENSING CABINET (ADC'S)

Model Number PAS4000

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

Carefusion received a medwatch (sus ms5062755) on (b)(6) 2016 from (b)(6).The medwatch does not discuss anesthesia system es directly in the event description section however it is listed in the product codes in the device information section.Carefusion reviewed all records from (b)(6) and did not find a record that correlates with the information in the medwatch.Neither the medwatch or any of the legacy health system records indicate patient or user harm.

Event Description

Customer reports that the pyxis es system including anesthesia system es experiences extended downtime.No patient harm reported.

• Brand Name: PYXIS ANESTHESIA SYSTEM (PAS)
• Type of Device: AUTOMATED DISPENSING CABINET (ADC'S)
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd.; san diego CA 92121
• Manufacturer Contact: allison suarez ; 10020 pacific mesa blvd.; san diego, CA 92121 ; 8586174995
• MDR Report Key: 5799211
• MDR Text Key: 49750468
• Report Number: 2016493-2016-00005
• Device Sequence Number: 1
• Product Code: BRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PAS4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1