| Class 2 Device Recall BD Pyxis(TM) Anesthesia Station 4000 |  |
Date Initiated by Firm | April 15, 2024 |
Date Posted | May 30, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1932-2024 |
Recall Event ID |
94527 |
Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
Product | BD Pyxis(TM) Anesthesia Station 4000, REF: 338 |
Code Information |
UDI: 10885403477829/ Serial Numbers:
15798662
15810061
15810065
15817562
15817565
15835217
15835218
15835220
15835221
15835222
15835223
15835224
15835225
15842733
15861006
15861007
15867540
15873126
15918237
15924975
15924976
15924977
15931453
15931454
15931455
15931456
15931457
15931458
15931459
15931460
15931461
15931462
15931463
15931464
15937528
15937529
15937530
15937531
15939257
15939258
15939259
15939260
15939957
15939958
15939960
15939961
15939962
15939963
15939964
15939965
15939966
15939967
15939968
15990642
15991836
15991837
16003697
16012922
16012923
16012924
16012925
16012926
16012927
16012928
16012929
16016868
16040839
16051442
16057728
16058994
16060051
16060052
16060053
16060054
16060055
16060056
16060057
16060058
16060048
16060966
16060962
16085461
16085475
16085476
16085477
16085478
16085479
16085480
16085481
16085482
16085483
16085484
16085485
16203788
16389146
13946913
14186949
14394813
14571778
14680456
14738938
|
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
|
Manufacturer Reason for Recall | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
FDA Determined Cause 2 | Component design/selection |
Action | On May 2, 2024, CareFusion, a subsidiary of Becton, Dickinson and company issued a "Urgent Medical Device Correction", to affected consignees via Fed-Ex by 2-day mail and email. CareFusion ask consignees to take the following actions:
1. If fluid spills in or near the BD Pyxis" MedStation" or BD Pyxis"Anesthesia Station, clean it up immediately. Divert the spilled liquid from any seams or openings.
2. In the event of an accidental fluid spill on the system or in a drawer:
A. Stop use of the device
B. Immediately remove power to the device (unplug from the wall)
C. Quarantine the device and notify BD service personnel at 1-800-727-6102
D. If smoke or fire occurs, determine if healthcare workers and patients need to be distanced or evacuated, and follow internal policies and procedures.
E. Follow facility downtime policies and procedures to obtain medications needed for patient care.
3. Per BD Pyxis" MedStation" labeling, never store or place liquids on the station. It is recommended to not overfill drawers; use drawer liners and store items containing liquids in the bottom of the BD Pyxis" MedStation" 4000 and BD Pyxis" MedStation" ES devices to minimize potential fluid ingress to the entire device.
4. It is best practice to have monitoring of the environment with automated smoke/fire alarms and sprinkler systems to extinguish any fire. Downtime policies and procedures should include a process for obtaining medications from another device or from pharmacy during downtime.
5. Appendix A provides updated Warnings, Cautions and recommendations regarding fluid ingress. Please post Appendix A to all Pyxis" MedStation" and Pyxis" Anesthesia Stations until updated Safety Guides are available.
6. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedStation or BD Pyxis" Anesthesia Station devices to.
7. Complete the attached Customer Response Form and return to the BD c |
Quantity in Commerce | 102 units |
Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|