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

Model Number	500004500500
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank mini, the drawer failed to open.As part of the investigation, it was determined that an excessive current on the circuit board.The excessive current thermally damaged u501 (voltage regulator).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, 26-apr-2021 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 drawer failure was confirmed during field service engineer (fse) testing and subsequently confirmed in the dchu inspection process.According to work order (b)(4), to resolve the drawer issue, field service engineer (fse) replaced pyxibus module controller (pmc) board on full height drawer 1.During dchu visual inspection: part number (p/n) 151730-21 or part name pcba pmc pyxis mini fw1-12: the returned pmc mini drawer board was externally inspected for any irregularities.U501 (regulator ic) was observed thermally damaged.There were no other anomalies observed.During dchu testing: part number (p/n) 151730-21 or part name pcba pmc pyxis mini fw1-12: due to the thermal damage observed on u501 further testing could not be performed.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: the root cause of the reported drawer failure was identified and attributed to an excessive current on the circuit board.The excessive current thermally damaged u501 (voltage regulator).

• Brand Name: BD Pyxis¿ MedBank Mini
• 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: 50315930
• Report Number: 2016493-2026-56132
• Device Sequence Number: 18654020
• Product Code: BRY
• UDI-Device Identifier: 10885403512582
• UDI-Public: (01)10885403512582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/17/2026

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: 500004500500
• Device Catalogue Number: 000000000000000349
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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