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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. BD Pyxis¿ MedBank Mini; Automated Dispensing Cabinet Back to Search Results
Model Number 500004500500
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/02/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank mini drawer was failed to open.The customer reported that a malfunction took place when the user tried to dispense medication to the patient.However, there were no delay 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, 02-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.Upon investigation of the actual device used in this incident, it was determined that the drawer was failed to open.A technical support specialist remoted into the system and found zones 07 and 08 were disabled.Re-enabled the affected drawers and verified functionality.Customer successfully issued the medication after the change.Issue resolved.The system functioned as intended after the technical support specialist troubleshot the device.
 
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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 Key50929286
Report Number2016493-2026-66943
Device Sequence Number10749657
Product Code BRY
UDI-Device Identifier10885403512582
Combination Product (Y/N)N
Initial Reporter StateFL
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 Health Professional,User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/04/2026
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 Number500004500500
Device Catalogue Number349
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 09/02/2026
Initial Report FDA Received Date09/29/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured04/02/2021
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 Number1
Patient SexUnknown
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