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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ Pro MedStation Secure Tower Aux; Cabinet, Table And Tray, Anesthesia

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CAREFUSION 303, INC. BD Pyxis¿ Pro MedStation Secure Tower Aux; Cabinet, Table And Tray, Anesthesia Back to Search Results
Model Number 500001004005
Medical Device Problem Codes Break (1069); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Activation Failure (3270)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/03/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ pro medstation secure tower aux, tower 1 had latch issue and it was intermittently failing.The customer stated that this malfunction occurred while dispensing the medication which caused a delay to the patient care.There were no adverse events or injuries reported based on this event.
 
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
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Brand Name
BD Pyxis¿ Pro MedStation Secure Tower Aux
Common Device Name
Cabinet, Table And Tray, Anesthesia
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 Key50070569
Report Number2016493-2026-50105
Device Sequence Number21422962
Product Code BRY
UDI-Device Identifier10885403517839
UDI-Public(01)10885403517839
Combination Product (Y/N)N
Initial Reporter CountryCA
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 Foreign,Health Professional,User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/03/2026
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 Number500001004005
Device Catalogue Number1152-00
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 07/03/2026
Supplement Date Received by Manufacturer08/03/2026
Initial Report FDA Received Date07/29/2026
Supplement Report FDA Received Date08/11/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/09/2026
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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