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

Model Number	500004500001
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071); Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux, the drawer jammed.As per part investigation, it was determined that thermal damage to component u501 on the pcba pmc pyxis mini and failure of both pcba dwr cntlr mini.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, 07-jun-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.Part analysis: the reported condition of drawer jammed was confirmed by fse and subsequently confirmed in the dchu testing and inspection process.According to work order (b)(4), the field service engineer (fse) reported that drawers 11 and 12 failed, and the main pyxibus board had missing leds.The fse replaced the drawer controller boards and the main pyxibus module controller (pmc) board.The customer inventory was verified with no issues observed.During dchu visual inspection: pn 151730-21: the unit revealed signs of thermal damage, specifically on component u501.No fluid ingress, loose components or other anomalies were observed.Pn 151722-01: both units were received in good condition with no signs of physical damage, loose components, fluid ingress or missing components.During dchu testing: pn 151730-21: no testing was required due to evidence of thermal damage observed on the u501 component.Pn 151722-01: pcba dwr cntlr mini were evaluated on an esd-protected surface using a calibrated digital multimeter in ohms mode.A measurement between tp505 (gnd) and tp502 (5v1) showed 0.2 ohms (expected >1000 ohms), indicating a short circuit.No further testing was necessary.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: the root cause was identified as thermal damage to component u501 on the pcba pmc pyxis mini resulting from an electrical failure.This damage compromised communication and control signals, preventing the drawer from opening properly and leading to overall system malfunction.Additionally, it was determined that the failure of both pcba dwr cntlr mini units was generated by a short circuit on diode d501 and q501 which led to circuit instability and compromised the drawer's functionality.

• Brand Name: BD PYXIS¿ MEDBANK TOWER AUX
• 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 ; 8586172000
• MDR Report Key: 25795806
• Report Number: 2016493-2026-45071
• Device Sequence Number: 17614728
• Product Code: BRY
• UDI-Device Identifier: 10885403512575
• UDI-Public: (01)10885403512575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/09/2026

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: 500004500001
• Device Catalogue Number: 169-141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown