MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ ES SERVER; AUTOMATED DISPENSING CABINET

Model Number	500001002501
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when using the bd pyxis¿ es server, several patients were merged in epic.However, both primary ids remained admitted in the system and continued to share the same visit id in pyxis.As a result, one of the primary id and visit id combinations had to be manually discharged.The customer was seeking to understand why the merge message did not correctly resolve the duplicate patient accounts in pyxis.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Additional information: section h imdrf annex codes.Correction: medical device catalog, unique identifier (udi), medical device serial, medical device model, concomitant med prod data and section h device manufacture date.D4 & h4: serial number, catalog, model, unique device identifier and manufacturer date not available.Upon investigation of the actual device used in this incident, it was determined that the a40 merge message had not resolved the duplicate records.A technical support specialist (tss) dialed into server and discovered that two separate primary ids existed, each with its own visit id.The customer mentioned that the attempts to send a merge message had failed, and review showed that the a40 merge message had not been sent to bd because the msh 4 field lacked a required value.The interface team explained the hl7 merge related message types, a40 was used to merge two patients that already existed in es, a42 was used to merge visits when the target mrn could either exist or not exist, a45 moved a visit to another medical record number (mrn) under similar conditions, a47 changed a patients identifier when the target mrn did not previously exist in es, and a50 updated or changed an existing visit number.The system functioned as intended after the technical support specialist assessed the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ es server, several patients were merged in epic.However, both primary ids remained admitted in the system and continued to share the same visit id in pyxis.As a result, one of the primary id and visit id combinations had to be manually discharged.The customer was seeking to understand why the merge message did not correctly resolve the duplicate patient accounts in pyxis.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ ES SERVER
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; 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 ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 24567197
• Report Number: 2016493-2026-12770
• Device Sequence Number: 9507736
• Product Code: BRY
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 03/17/2026

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: 500001002501
• Device Catalogue Number: 135343-01
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SN: (B)(6), LOCATION: IT.
• Patient Sex: Unknown