Description of Event or Problem · 1
THE ANESTHESIA SYSTEMS THAT HAVE BEEN CLASSIFIED AS A MEDICAL DEVICE BY FDA HAVE A DESIGN FLAW THAT CREATES AN ENVIRONMENT FOR SERIOUS ADVERSE EVENTS TO OCCUR. THE DESIGN FLAW IS THE WAY THE SYSTEM AUTOMATICALLY ASSIGNS POCKET NUMBERS WITH THE DRAWERS. BY DESIGN, THE SYSTEM WILL AUTOMATICALLY ASSIGN THE LOWEST NUMBER FOR MULTIPLE POCKETS. THIS ASSIGNMENT OF POCKET NUMBERS CANNOT BE OVERRIDDEN AND MUST BE USED. THIS ASSIGNMENT OF THE NUMBERS COULD ASSIGN A POCKET WITH THE NUMBER OF 3 ON THE SAME ROW OF POCKETS BETWEEN POCKET NUMBER 8 AND POCKET NUMBER 10. MEDS THAT NEED TO BE REMOVED BY THE PRACTITIONER FROM POCKET 4 MAY ACCIDENTALLY BE REMOVED FROM POCKET 10 BECAUSE NUMBER 3 POCKET IS ADJACENT AND BETWEEN POCKETS 8 AD 10. THIS AUTOMATIC NUMBER ASSIGNING BY THE ANESTHESIA PYXIS SYSTEM IS NOT HOW NON ANESTHESIA PYXIS MEDSTATIONS ARE NUMBERED. THE POCKETS FOR THE PYXIS MEDSTATIONS ARE MANUALLY NUMBERED CONSECUTIVELY FROM LEFT TO RIGHT AND FROM FRONT TO BACK. POCKETS THAT ARE MANUALLY NUMBERED WILL NOT HAVE POCKETS NUMBERED THAT ARE OUT OF SEQUENCE, AND, THEREFORE, WOULD NOT LEAD TO MEDICATIONS BEING REMOVED BY THE PRACTITIONER IN ERROR. BECAUSE OF THE NATURE OF THE MEDICATIONS THAT ARE USED IN SURGERY AND STOCKED IN THESE ANESTHESIA SYSTEMS, THE POTENTIAL FOR SERIOUS ADVERSE EVENTS WILL EXIST UNTIL THIS DESIGN FLAW IS CORRECTED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: ANESTHESIA MEDICATION AUTOMATED DISPENSING CABINET.