MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ ES Refrigerator; Automated Dispensing Cabinet

Model Number	500001004500
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es refrigerator failed and displayed a "device not detected on bus" error message.The customer also reported that the network cable had been disconnected from the machine.The customer tried to reboot and recover, but the issue persisted the customer stated that this malfunction occurred while dispensing the medication, and the user managed to get the medication from another station.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
A review of the complaint history for sn (b)(6) was performed in salesforce which did not locate similar complaint(s) with the same failure mode for this serial number.A review of the device history record for sn (b)(6) was performed from the date of manufacture, 18-jul-2019 and confirmed that this device was not previously returned for servicing and there were no production failures which correlates to the customer reported issue.Upon investigation of the actual device used in this incident, it was determined that the helmer refrigerator was not detected on bus.A field service engineer (fse) performed troubleshooting and determined that the ethernet cable for the helmer refrigerator had become disconnected.The fse reconnected the ethernet cable, restoring communication and bringing the refrigerator back online.The pharmacy technician then completed an inventory count to verify functionality.The refrigerator operated normally, resolving the issue.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD Pyxis¿ ES Refrigerator
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50816612
• Report Number: 2016493-2026-64389
• Device Sequence Number: 10152093
• Product Code: BRY
• UDI-Device Identifier: 10885403510427
• UDI-Public: (01)10885403510427
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 500001004500
• Device Catalogue Number: 137730-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown