GETINGE MODEL 533HC

Description of Event or Problem

SURGICAL INSTRUMENTS WERE USED DURING A PT PROCEDURE THAT WERE PROCESSED IN A STEAM STERILIZATION CYCLE THAT ABORTED PRIOR TO COMPLETION. THE HOSP OPERATOR WAS UNAWARE THAT THE CYCLE DID NOT SUCCESSFULLY COMPLETE AND RELEASED THE LOAD FOR USE. THE LOAD CONTAINED 3 INSTRUMENTS, 1 WAS USED ON THE PT. A SERVICE TECH WAS CALLED TO EVAL THE STERILIZER. THE SURGEON WAS NOTIFIED OF THE INCOMPLETE CYCLE AND ANTIBIOTIC THERAPY WAS INITIATED TO THE PT AS A PRECAUTION. NO STATUS OF THE PT WAS RELEASED.

Additional Manufacturer Narrative

DURING A RETROSPECTIVE REVIEW OF THE COMPLAINT FILES, IT WAS DETERMINED THAT THIS EVENT SHOULD HAVE BEEN REPORTED. AT THE TIME, THE DECISION NOT TO REPORT WAS BASED ON USER ERROR CAUSED THE EVENT AND THERE WAS NO PT INJURY REPORTED. HOWEVER, AFTER FURTHER REVIEW, IT WAS FELT THAT THE EXPERT SHOULD HAVE BEEN FILED. THE STERILIZER CONTROLS FUNCTIONED TO SPECIFICATION WHEN SENSING THE HIGH TEMPERATURE CONDITION WITHIN THE STERILIZER AND ABORTING THE CYCLE. A SERVICE TECH WAS CALLED TO EVALUATE THE STERILIZER AND WAS UNABLE TO REPEAT THE FAILURE MODE. WHEN A STERILIZER ABORTS, THE CYCLE ABORT IS PRINTED ON THE DATALOGGER STRIP RECORD, THE CONDITION IS TEMPORARILY DISPLAYED ON THE SCREEN, AND THE STERILIZER GOES THROUGH ITS ABORT PROTOCOL. THE DISPLAY WILL NOT INDICATE THE CYCLE WAS SUCCESSFUL (IF IT WAS SUCCESSFUL, A GREEN "OK" BAR IS DISPLAYED) AND THE DOOR REMAINS SEALED UNTIL THE OPERATOR MANUALLY UNSEALS IT. THIS STERILIZER ERROR HANDLING PROTOCOL HAS BEEN THE SAME FOR MANY YEARS (INCLUDING PREVIOUS MODELS). THE HOSP OPERATOR DID NOT FOLLOW STANDARD OPERATING PROCEDURES AND DID NOT REVIEW THE DATA LOGGER RECORD PRIOR TO RELEASING THE INSTRUMENTS FOR USE. GETINGE PROVIDED IN-SERVICE TRAINING TO THE HOSP OPERATORS REGARDING ERROR HANDLING. IN ADDITION, A SOFTWARE CHANGE WAS MADE FOR FUTURE PRODUCTION SHIPMENTS TO REQUIRE OPERATORS CLEAR THE ERROR CODES FROM THE DISPLAY PRIOR TO UNSEALING THE STERILIZER DOOR.