FDA Adverse Event Death Summary report: N

BD PYXIS MEDSTATION - VERSION E5

MDR report key: 19341401 · Received May 16, 2024

Report

Report Number
MW5155057
Event Type
Death
Date Received
May 16, 2024
Date of Event
April 19, 2024
Report Date
May 10, 2024
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

(B)(6) 2024 ARRIVED TO ED (EMERGENCY DEPT) VIA EMS (EMERGENCY MEDICAL SERVICES) - STEMI (ST ELEVATION MYOCARDIAL INFARCTION) WAS CALLED AT 12:42PM. PATIENT WAS PLACED ON TABLE IN CATH LAB. CATH LAB PERSONNEL WERE UNABLE TO ACCESS PYXIS. PHARMACY WAS NOTIFIED. PHARMACY UNLOCKED PYXIS BUT THE INTERNAL COMPARTMENTS TO DRAWERS WHICH HOUSED MEDICATIONS WERE UNABLE TO BE ACCESSED. THIS LEAD TO NURSES NOT BEING ABLE TO GET MEDICATIONS FROM THIS PYXIS. NURSING AND PHARMACY HAD TO RUN TO ANOTHER AREA TO A DIFFERENT PYXIS TO GET MEDICATIONS (LEVOPHED, NEOSYNEPHRINE, AND AMIODARONE) WHICH CAUSED A DELAY IN TREATMENT AND ADMINISTRATION OF CRITICAL MEDICATIONS. AT APPROXIMATELY 5:05 P.M. ON (B)(6) 2024, ED MANAGER, REPORTED TO EMERGENCY MANAGEMENT (EM) THE HOSPITAL HAD A FACILITY-WIDE PYXIS ISSUE VIA TEXT. THE PHARMACY STAFF WAS NOTIFIED UNITS WERE UNABLE TO PULL MEDS AND THE PYXIS SHOWED A CRITICAL OVERRIDE BUT WHEN STAFF SELECTED IT, IT DIDN'T WORK. AT 5:23 P.M.- EM, INCIDENT COMMAND ACTIVATED. AN ISD (INFORMATION SERVICES DIVISION) TICKET WAS ENTERED AND IN THE INTERIM, UNITS WILL CALL THE PHARMACY FOR MEDICATIONS THAT NEED TO BE GIVEN. THE TEAM IS LEARNING THE FAILURE IS NOT SPECIFIC TO (B)(6), BUT SYSTEM-WIDE. THE PHARMACY IS USING RUNNERS TO DELIVER MEDICATIONS. AT 6:07 P.M., ED LEADERSHIP HAD PHARMACY PULL AN INTUBATION, PRECIPITOUS DELIVERY AND TNK BOX AS BACKUP. AT 6:14 P.M.- LSD DIRECTOR, COMMUNICATED THE FIX WAS IDENTIFIED AND WAITING ON NOTIFICATION OF COMPLETION. AT 6:31 P.M.- ISD DIRECTOR COMMUNICATED THE ISD PHARMACY TEAM IS ENGAGED AND THE MACHINES ARE WORKING ON OVERRIDE. OTHER (B)(6) ENTITIES WENT SMOOTHLY ON AN OVERRIDE, BUT (B)(6) CONTINUES TO HAVE AN INTERTACE ISSUE AND ISD IS ENGAGED WITH BD (VENDOR). THE NURSE SUPERVISOR REPORTED MSO, PCU, AND ICU ARE OPERATIONAL. 6:36 P.M.- THE PHARMACY ADMIN DIRECTOR REPORTED THERE WERE 2 DIFFERENT ISSUES. ONE WAS ISOLATED TO (B)(6) WHICH DIDN'T ALLOW US TO ACCESS THE OVERRIDE FUNCTION. SECOND IS SYSTEM-WIDE AND ORDERS ARE NOT CROSSING OVER. THIS IS NOT YET RESOLVED SO NURSES WILL NEED TO PULL ALL MEDS ON OVERRIDE. AT 6:40 P.M. ED REPORTS NEW ORDERS ARE NOW CROSSING OVER AND ISD REPORTED THE MACHINES WILL GO OFF OVERRIDE ONCE THE INTERTACE CONNECTS NOW THAT NEW ORDERS ARE FLOWING. 6:47P.M. - ISD REPORTED ALL CLEAR. ON (B)(6) 2024 7:40AM: PYXIS IS STILL DOWN ON PATHS, OR 5, 6, AND ENDO 2 WITH NO ETA. AT 8:53 A.M.- PHARMACY REPORTS PATHS AND ANESTHESIA MACHINES RESOLVED AND OPERATIONAL. AT 9:51 A.M.- PHARMACY REPORTS ALL STATIONS ARE NOW COMMUNICATING TO THE SERVER AND THEY WILL MAINTAIN STATIONS ON CRITICAL OVERRIDE WHILE BO RESEARCH OTHER OUTSTANDING ISSUES. EMS CALLED TO RESIDENCE FOR PT IN CARDIAC ARREST. ON ARRIVAL PT AOX4, BYSTANDERS REPORTED PT COMPLAINED OF SHORTNESS OF BREATH AND LOSS CONSCIOUSNESS, FALLING AND HITTING HIS HEAD. PT WAS REPORTEDLY PULSELESS AND REQUIRED APPROX. 2 MINS OF CHEST COMPRESSIONS BEFORE BECOMING ALERT. EKG DONE ON SCENE, SHOWED ST ELEVATION. CODE STEMI INITIATED BY EMS. ARRIVED AT HOSPITAL, SENT TO CT TO R/O (RIGHT OCCIPITAL) HEAD TRAUMA. CT NEGATIVE, PROCEEDED TO CATH LAB. FINAL IMPRESSIONS: ACUTE CARDIOGENIC SHOCK FOLLOWING CARDIOPULMONARY ARREST AND RESUSCITATION, SEVERE MULTIVESSEL CORONARY DISEASE, SUCCESSFUL IMPLANTATION OF IABP(INTRA-AORTIC BALLOON PUMP, RADIOFREQUENCY ABLATION), DESPITE SUCCESSFUL PCI OF THE CIRCUMFLEX OCCLUSION AND SEVERE OSTIAL LAD DISEASE THE PT DEVELOPED VT (VENTRICULAR TACHYCARDIA) WHICH EVENTUALLY DETERIORATED INTO PEA(PULSELESS ELECTRICAL ACTIVITY) AND DID NOT SURVIVE DESPITE MAXIMAL RESUSCITATIVE EFFORTS. DISPOSITION: PT EXPIRED (THERE IS NO DIRECT CORRELATION BETWEEN THE DEATH AND THE PYXIS MALFUNCTION, THOUGHT IT DID CONTRIBUTE TO THE STRESS LEVEL OF THE STAFF).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
743279 BD PYXIS MEDSTATION - VERSION E5 CABINET, TABLE AND TRAY, ANESTHESIA BRY CAREFUSION 303, INC. BD KMAT 323

Patients

Seq Age Sex Outcome Treatment
1 72 YR Male Death AMIODARONE| LEVOPHED| NEO-SYNEPHRINE