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

Model Number	500004500000
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower could not be powered on.The monitor remained powered on; however, the cabinet had no power, the fan was not spinning and attempts to restore power using different outlets and power cords were unsuccessful.As per part investigation, it was determined that the issue was attributed to physical damage caused by fluid ingress in the pwr sply univ ac 36vdc 265w (pn 136713-01), resulting in a short/miscommunication.Additionally, the pcba ccib m&m (pn 151801-01) was found to be faulty.Although no specific failed component was identified, the board failure prevented the drawers from being detected.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, 25-oct-2022 and confirmed that this device was not previously returned for servicing and there were no production failures which correlates to the customer reported issue.The reported condition of cabinet no power was confirmed by fse and subsequently confirmed in the dchu testing and inspection process.According to work order (wo) (b)(4).The power supply fan was not spinning because the bolts holding it in place were touching the fan blade.The bolts were loosened slightly to allow the fan blade to spin freely.The station still appeared to have boot-up issues, and a new power supply was planned for replacement.Logmein was not functioning properly.Medbank support was contacted and remotely reinstalled the application.Afterward, the medapp did not function properly and remained stuck on connecting.Medbank support was able to get the medapp to boot up, but a cabinet controller not found issue was encountered.Medbank support recommended replacing the comms led board and cabinet controller, which was done.However, the same issue persisted.Medbank support was contacted again and modified multiple station settings because the station had been configured as a non-sync station.Afterward, the medapp operated correctly, but the drawers were still not functioning properly.The power supply was replaced because it was not providing sufficient power.During dchu visual inspection: pn 151800-11: was received in good condition, with no signs of physical damage, fluid ingress, loose or missing components.Pn 151801-01: was received in good condition, with no signs of physical damage, fluid ingress, loose or missing components.Pn 136713-01: was received with signs of fluid ingress.During dchu testing: pn 151800-11: dchu testing confirmed proper operation.No errors were observed, and all drawers were detected correctly.Pn 151801-01: dchu testing confirmed the board was not functioning as intended, as no drawers were detected by the system.Pn 136713-01: due to the presence of fluid ingress, dchu testing and hta testing are not required.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: the root cause of the reported failure cabinet no power is attributed to physical damage caused by fluid ingress in the pwr sply univ ac 36vdc 265w pn 136713-01 resulting in a short/miscommunication.Additionally, the pcba ccib m&m pn 151801-01 was found to be faulty.Although no specific failed component was identified, the board failure resulted in the drawers not being detected.

• Brand Name: BD Pyxis¿ MedBank Tower
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; 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 ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50914093
• Report Number: 2016493-2026-66752
• Device Sequence Number: 5370165
• Product Code: BRY
• UDI-Device Identifier: 10885403512568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 500004500000
• Device Catalogue Number: 169-27
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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