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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ MEDBANK TOWER AUX; AUTOMATED DISPENSING CABINET

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CAREFUSION 303, INC. BD PYXIS¿ MEDBANK TOWER AUX; AUTOMATED DISPENSING CABINET Back to Search Results
Model Number 500004500001
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/13/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux, the user was unable to log in to issue items and cubex app was not responding.The customer stated that this malfunction occurred while dispensing the medication.However, there were no delays or 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, 22-oct-2025 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, the technical support specialist (tss) noted that after restarting the aio using the power button, the screen remained stuck on connecting.Initial checks showed light on the network cable connector, but later no light was observed despite confirming a tight connection and restarting via the cubex app.Facility was last online with pending sync, and customer was unaware of any power or network changes.Customer was advised to contact local it to verify the status of the network port where the aio is connected.Customer reported that the issue was resolved by the facility's it department.The system functioned as intended after the technical support specialist investigated the device.
 
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Brand Name
BD PYXIS¿ MEDBANK TOWER AUX
Common Device Name
AUTOMATED DISPENSING CABINET
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92130
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS S.A DE C.V.
parque sur, el realito
blvd. 2000
tijuana 22250
MX   22250
Manufacturer Contact
brett wilko
10020 pacific mesa blvd.
san diego, CA 92130
MDR Report Key24797362
Report Number2016493-2026-19360
Device Sequence Number21499470
Product Code BRY
UDI-Device Identifier10885403517174
UDI-Public(01)10885403517174
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/18/2026
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 Number500004500001
Device Catalogue Number1146-00
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 03/13/2026
Initial Report FDA Received Date04/07/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured10/22/2025
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
Usage of Device A
Patient Sequence Number1
Patient SexUnknown
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