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Pyxis 327 (UDI 10885403533242)Recalls & reported problems

Carefusion 303, Inc. · Pyxis Anesthesia System ES · Class 1

Quick summary

This Pyxis anesthesia station is a cabinet with locked drawers that dispense medication in operating rooms. Its reports often describe software errors, drawers that fail to open or lock, and electrical or connection faults, and some mention delays in patient care. The 3,890 reports include 1 death and 1 injury. No recalls name this device. Reports rose to 3,564 in the last 12 months from 326 in the previous 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
4,304
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4,304 adverse event reports that list this exact device (DI 10885403533242), received between Jan 25, 2025 and Sep 30, 2026 — classified as 1 death, 1 injury, 4,297 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (831 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 3 reportsFeb 2025: 12 reportsMar 2025: 18 reportsApr 2025: 15 reportsMay 2025: 12 reportsJun 2025: 6 reportsJul 2025: 14 reportsAug 2025: 9 reportsSep 2025: 60 reportsOct 2025: 177 reportsNov 2025: 331 reportsDec 2025: 371 reportsJan 2026: 183 reportsFeb 2026: 285 reportsMar 2026: 362 reportsApr 2026: 387 reportsMay 2026: 363 reportsJun 2026: 452 reportsJul 2026: 458 reportsAug 2026: 348 reportsSep 2026: 438 reportsOct 2026: 0 reports202420252026458
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Application Program Problem831
  • Electrical /Electronic Property Problem745
  • Circuit Failure478
  • Installation-Related Problem455
  • Loose or Intermittent Connection395
  • Break338
  • Application Network Problem305
  • No Apparent Adverse Event282

Patient problems

  • No Clinical Signs, Symptoms or Conditions4,301
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Hemorrhage/Blood Loss/Bleeding1
  • Low Oxygen Saturation1

Recent adverse event reports

The 25 most recent of 4,304 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Contamination

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946185 ↗
  • MalfunctionSep 30, 2026Electrical /Electronic Property Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the Bio ID device displayed a "Maintenance Required" message.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946175 ↗
  • MalfunctionSep 30, 2026Loose or Intermittent Connection

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the drawer 2.1 was failed to open. Customer tried to recover but issue did not resolve. The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay to patient care. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945877 ↗
  • MalfunctionSep 30, 2026Insufficient Device Problem Information

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, draw 2.1 locked did not open and unable to recover. The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay to patient care. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945876 ↗
  • MalfunctionSep 30, 2026Circuit Failure; Installation-Related Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES received the error message "The network interface with name PYIET was not found". User had reinstalled the associated file twice as part of troubleshooting; however, the device continued to fail communication and remained offline.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945869 ↗
  • MalfunctionSep 30, 2026Loose or Intermittent Connection; Application Program Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the station screen went black, and the cabinet was reported as RSS offline.There were no delay or adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944979 ↗
  • MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the device displayed a black screen. The customer rebooted the device, but the issue was not resolved.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944976 ↗
  • MalfunctionSep 30, 2026Break

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES device was not communicating with the system. The user verified the non-communication issue on the Pyxis device and indicated that it was not related to the data port.The customer stated that this malfunction occurred while dispensing the medication and they were unable to access the medication, which caused a delay to the patient care. There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944973 ↗
  • MalfunctionSep 30, 2026Application Program Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES users were unable to log in to the AWS. A system reset was required to restore functionality and allow user access. The customer reported that this issue had been occurring frequently, resulting in repeated login failures and requiring multiple resets to regain access.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944937 ↗
  • MalfunctionSep 30, 2026Circuit Failure

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the cubie tray had failed to open. The customer stated that this malfunction occurred while dispensing medication to patients and caused delay in patient care. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944935 ↗
  • MalfunctionSep 30, 2026No Apparent Adverse Event

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, station was not communicating.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944934 ↗
  • MalfunctionSep 30, 2026Labelling, Instructions for Use or Training Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, station stock out was not populated on carousel for MedID (b)(6). The customer stated that this malfunction caused a delay in dispensing medication to patients. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944927 ↗
  • MalfunctionSep 30, 2026Misassembled

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the drawer was reported to be repeatedly failing. Attempts to recover the drawer using the Recover Storage Space function were unsuccessful, and the system displayed a Requires Maintenance message. The only successful method of recovery was manually unlocking the drawer with keys and accessing it from the rear of the unit. Additionally, the affected accessible drawer remained locked even during a procedure, preventing normal operation.The customer stated that this malfunction occurred while dispensing the medication.There were no adverse events or injuries reported due to this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944374 ↗
  • MalfunctionSep 30, 2026Mechanical Jam

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES system drawer maps did not populate consistently, preventing the decrementing function from being performed. However, there were no delay and adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944197 ↗
  • MalfunctionSep 30, 2026Insufficient Device Problem Information

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, count was not reflecting correct amount.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50943540 ↗
  • MalfunctionSep 30, 2026Insufficient Device Problem Information

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, medications were disappearing.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50943532 ↗
  • MalfunctionSep 30, 2026Contamination

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the drawer failed to recover.As per part investigation, it was determined that fluid ingress in the connector area of P/N 133456-03 ASSY, CTRL UNIT, 1X1, UL, which produced a miscommunication.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942745 ↗
  • MalfunctionSep 30, 2026Failure to Align

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES drawer 2.2 became locked during a case, would not open, and could not be recover. The customer stated that this malfunction occurred while dispensing the medication and caused a delay to the patient care. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942723 ↗
  • MalfunctionSep 30, 2026Application Program Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the matrix drawer map did not display on the screen when the drawers were opened during a case. users were unable to enter a waste amount on the device because the number keys were unresponsive.The customer reported that a malfunction took place when the user tried to dispense medication to the patient. There were no delay or adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942722 ↗
  • MalfunctionSep 30, 2026Circuit Failure; Loose or Intermittent Connection

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES the device was not detected on bus. The customer stated that this malfunction caused a delay in dispensing medication to patients. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942540 ↗
  • MalfunctionSep 30, 2026Component Missing

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the system drawer 2.1 was broken and the drawer had been subjected to excessive force during closure by the pharmacy technicians. When the drawer is opened fully, the right-side drops or sinks downward. The customer stated that this malfunction caused a delay in dispensing medication to patients. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942536 ↗
  • MalfunctionSep 30, 2026No Apparent Adverse Event

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, drawer 1.14 failed. Customer tried to reboot and recover but issue wasn't resolve. The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay to patient care. However, the user managed to retrieve the medication from another station. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942530 ↗
  • MalfunctionSep 30, 2026Circuit Failure

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES mini matrix pocket 1.6 extended completely outward and exposed all pockets when pulled, regardless of the number of medications in the drawer. The user confirmed when refilling, the drawer extended beyond the last pocket and produced a quiet buzzing noise, indicating that the drawer required further extension.The customer stated that this malfunction occurred while dispensing the medication.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942529 ↗
  • MalfunctionSep 30, 2026Application Network Problem; Application Program Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES, multiple machines entered Recovery Mode and could not be fully rebooted. The customer stated that the machines were disconnected from both the Ethernet network and power outlets during downtime in the OR space. After reconnecting the Ethernet and power connections to OR1 and OR6, the machines displayed a Recovery Mode error and failed to complete the startup process. Multiple reset attempts were performed by the technicians; however, the machines remained in Recovery Mode, preventing further troubleshooting and normal operation.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942481 ↗
  • MalfunctionSep 30, 2026Installation-Related Problem

    It was reported that when using the BD Pyxis¿ Anesthesia Station ES system machines were in recovery mode, and the technicians were unable to troubleshoot the errors displayed on the screen. The customer stated that this malfunction caused a delay in dispensing medication to patients. However, there were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942479 ↗

Other Cabinet, table and tray, anesthesia devices

All Cabinet, table and tray, anesthesia devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.