MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ Medflex 1000; Automated Dispensing Cabinet

Model Number	500004502000
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medflex 1000 the keyboard malfunctioned.As per part investigation, it was determined that the complaint was attributed to the physical damage of part pn 358591-01, which resulted in thermal damage and produced a functional failure that prevented proper keyboard functionality.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, 07-feb-2024 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 report condition of keyboard malfunction was confirmed during fse testing and subsequently confirmed in the dchu inspection process.According to work order # (b)(4), the field service engineer (fse) reported a keyboard cable frayed so the fse replaced the keyboard and the customer verified functionality.During dchu visual inspection: pn 358591-01: signs of a frayed cable with signs of thermal damage were observed on the visual inspection.During dchu testing: pn 358591-01: no dchu testing was required due to the frayed cable with signs of thermal damage observed during the visual inspection.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 keyboard malfunction is attributed to the physical damage of part pn 358591-01 which ultimately caused a thermal damage and produced a functional failure that prevents the proper keyboards functionality.

• Brand Name: BD Pyxis¿ Medflex 1000
• 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: 50932711
• Report Number: 2016493-2026-67252
• Device Sequence Number: 9563627
• Product Code: BRY
• UDI-Device Identifier: 10885403512704
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 500004502000
• Device Catalogue Number: 1139-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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