BD PYXIS MEDSTATION ES SYSTEM
Report
- Report Number
- 2016493-2024-00196
- Event Type
- Death
- Date Received
- May 14, 2024
- Date of Event
- April 23, 2024
- Report Date
- March 17, 2025
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403512667
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE STATION WAS MISTAKENLY LEFT IN INSTALLED MODE, AS A RESULT THE DEVICE WAS WORKING ON REMOVING PATCHES DURING THE PERIOD OF REPORTED EVENT. A FIELD SERVICE ENGINEER REPLACED HARD DRIVE, DOCKING BOARD, ALL-IN-ONE, COMMUNICATION SLED, AND REIMAGED THE STATION, PERFORMED FULL DATA SYNCHRONIZATION AND REBOOTED TO RESOLVE. THE SYSTEM WAS FUNCTIONAL AS INTENDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE CUSTOMER RELEASES ADDITIONAL INFORMATION REGARDING THE REPORTED DEATH EVENT.
SECTION B2 - UPDATED SELECTION FROM LIFE-THREATENING TO DEATH WITH THE DATE OF REPORTED DEATH EVENT. SECTION H1- UPDATED SELECTION FROM SERIOUS INJURY TO DEATH. SECTION H6 - UPDATED THE HEALTH EFFECT - IMPACT CODE.
THIS SUPPLEMENTAL REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA 10308384. THE LATE SUBMISSION OF THIS SUPPLEMENTAL REPORT IS DUE TO THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM 24-APR-2022 TO 23-APR-2024 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 ISSUE WAS RELATED TO THE DATABASE FAILED. THE FIELD SERVICE ENGINEER REPLACED THE ALL-IN-ONE SCREEN ASSEMBLY, REIMAGED THE HARD DRIVE, PERFORMED A COMPLETE DATA SYNCHRONIZATION, CONFIGURED THE TIME SETTINGS AND ENABLED AUTOMATIC LOGIN, AND DISABLED THE WINDOWS FIREWALL TO RESOLVE THE ISSUE. SUBSEQUENTLY, THE STATION WAS REBOOTED. THE SYSTEM FUNCTIONED AS INTENDED AFTER TROUBLESHOOTED BY THE FIELD SERVICE ENGINEER.
SECTION B5 - UPDATED THE ADVERSE EVENT WITH ADDITIONAL INFORMATION.
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM WAS FAILED, PREVENTING USER FROM REMOVING THE MEDICATIONS DURING A CATHETERIZATION PROCEDURE. CUSTOMER STATED THAT THERE WAS A DELAY TO ACCESS THE MEDICATIONS WHEN THE PATIENT WAS CODED AND THE REQUIRED MEDICATIONS WERE ZOFRAN, VERSED, AMIODARONE 360MG AND LEVOTHED 4MG. THE CUSTOMER REPORTED PATIENT DEATH BUT DID NOT PROVIDE DETAILED INFORMATION ABOUT THE EVENT. THE MANUFACTURER REACHED OUT TO CUSTOMER TO UNDERSTAND THE PATIENT'S INITIAL CONDITION AND THE SPECIFIC SERIES OF EVENTS THAT LED TO PATIENT DEATH.
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM WAS FAILED, PREVENTING USER FROM REMOVING THE MEDICATIONS DURING A CATHETERIZATION PROCEDURE. CUSTOMER STATED THAT THERE WAS A DELAY TO ACCESS THE MEDICATIONS WHEN THE PATIENT WAS CODED AND THE REQUIRED MEDICATIONS WERE ZOFRAN, VERSED, AMIODARONE 360MG AND LEVOTHED 4MG. THE CUSTOMER REPORTED PATIENT DEATH BUT DID NOT PROVIDE DETAILED INFORMATION ABOUT THE EVENT. THE MANUFACTURER REACHED OUT TO CUSTOMER TO UNDERSTAND THE PATIENT'S INITIAL CONDITION AND THE SPECIFIC SERIES OF EVENTS THAT LED TO PATIENT DEATH. IT WAS INCONCLUSIVE THAT THE DELAY REPORTED IN THIS CASE CONTRIBUTE TO THE PATIENT'S DEATH.
ADDITIONAL EVENT INFORMATION WAS RECEIVED FROM THE CUSTOMER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE CARDIAC THROMBUS AND HYPOTENSION. THE PATIENT WAS BROUGHT TO THE CARDIAC CATH-LAB FOR PLACEMENT OF AN INTRA-AORTIC BALLOON PUMP (IABP) AND ANGIOPLASTY. WHILE IN THE CATH-LAB A NOREPINEPHRINE DRIP AND PHENYLEPHRINE PUSH WAS ORDERED. THE DEVICE EXPERIENCED THE RECALL EVENT AND THUS THE NURSE WAS UNABLE TO OBTAIN THE MEDICATIONS FROM MED ES DEVICE. THE NURSE THEN WENT TO ANOTHER MED ES DEVICE LOCATED APPROXIMATELY 150 FEET AWAY FROM THE FIRST DEVICE AND WAS ABLE TO OBTAIN THE MEDICATION. THE MEDICATIONS WERE ORDERED AT 13:31 AND WERE ADMINISTERED TO THE PATIENT AT 13:37 (WITHIN 6 MINUTES). THE PATIENT RESPONDED WELL TO THE ADMINISTRATION OF THE MEDICATION. DURING THE PROCEDURE THERE WAS A COMPLICATION WITH THE IABP BALLOON CONSOLE. THE CARDIAC CATHETERIZATION WITH ANGIOPLASTY AND STENTING WAS PERFORMED. WHILE STILL IN THE CATH-LAB THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND THEN PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. DESPITE RESUSCITATION EFFORTS THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576422 | BD PYXIS MEDSTATION ES SYSTEM | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 323 | 10885403512667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| L |