500-SERIES

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF INCIDENT WITH THE 533HC STERILIZER. AS IT WAS STATED BY THE GETINGE TECHNICIAN STERILIZER WAS LEAKING FROM THE BOTTOM. TECHNICIAN PERFORMED AN INSPECTION AND FOUND THAT ONE OF THE ½ INCH TEES WITH HOSE ASSEMBLIES SCREW INTO WAS LEAKING AT THE TEE JUNCTION WHERE IT CONNECTS TO ½ INCH NIPPLE. TECHNICIAN SHUT DOWN THE MACHINE, DEPRESSURIZE AND PERFORM THE REPAIR. AFTER REASSEMBLY TECHNICIAN BEGAN PRESSURIZING THE DEVICE AND PERFORMING INSPECTION AND NOTICE THAT THE HOSE ASSEMBLY STARTED LEAKING, WHEN WIGGLED IT SLIGHTLY THE HOSE ASSEMBLY HAD FAILED, AND STEAM LEAKED ON THE TECHNICIAN FOREHEAD. TECHNICIAN WENT TO THE ER TO TREAT THE BURN. THE BURN WAS CLASSIFIED ACCORDING TO TECHNICIAN AS 2ND DEGREE BURN. WE DECIDED TO REPORT THE ISSUE BASED ON EVENT THAT LED TO SERIOUS INJURY. GETINGE TECHNICIAN ORDER NEW HOSE AND FINALIZED THE REPAIR ON 4TH OCTOBER 2024. THE UNIT WAS TESTED AND RETURNED TO CUSTOMER. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE FOR 500-SERIES HEALTHCARE STERILIZERS WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE FIRST ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS OF ITS KIND. THE INVESTIGATED EVENT HAS LED TO SERIOUS INJURY. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATIONS DUE TO HOSE ASSEMBLY STARTED LEAKING AND CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON THE PERFORMED ROOT CAUSE ANALYSIS AND INPUT FROM THE SUBJECT MATTER EXPERT AND THE GETINGE TECHNICIAN WHO VISITED THE CUSTOMER WE CONCLUDE THAT THE ROOT CAUSE OF THE INCIDENT IS THE TECHNICIAN'S FAILURE TO ADHERE THE PROCEDURES OUTLINED IN THE SERVICE MANUAL. SERVICE TECHNICIANS ARE TRAINED ON THE SERVICING ACTIVITIES OF SPECIFIC STERILIZER AND PPE (INCLUDING EYE PROTECTION) ARE ALSO MANDATORY WHEN OPERATING ON STEAM STERILIZERS. HOSE CONDITION WAS THE CONTRIBUTING FACTOR TO DESCRIBED EVENT. THE COMPONENT HAS BEEN RETURNED TO MANUFACTURER AND HAS BEEN ANALYZED. A SIGNIFICANT AMOUNT OF MINERAL DEPOSITS WAS FOUND ON THE SECOND FITTING OF THE HOSE. THE TECHNICIAN REPORTED THE HOSE WAS REPLACED APPROXIMATELY ONE MONTH PRIOR TO THE INCIDENT. HOWEVER, THE HIGH LEVEL OF MINERAL DEPOSITS IS INCONSISTENT WITH THIS TIMELINE. THESE MINERAL DEPOSITS MAY ALSO BE CAUSED BY PREVIOUS DAMAGE OF THE HOSE (MINOR LEAK DURING USE) AND/OR POOR MEDIA QUALITY AT CUSTOMER. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES, WE WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.

Description of Event or Problem

GETINGE BECAME AWARE OF INCIDENT WITH THE 533HC STERILIZER. AS IT WAS STATED BY THE GETINGE TECHNICIAN STERILIZER WAS LEAKING FROM THE BOTTOM. TECHNICIAN PERFORMED AN INSPECTION AND FOUND THAT ONE OF THE ½ INCH TEES WITH HOSE ASSEMBLIES SCREW INTO WAS LEAKING AT THE TEE JUNCTION WHERE IT CONNECTS TO ½ INCH NIPPLE. TECHNICIAN SHUT DOWN THE MACHINE, DEPRESSURIZE AND PERFORM THE REPAIR. AFTER REASSEMBLY TECHNICIAN BEGAN PRESSURIZING THE DEVICE AND PERFORMING INSPECTION AND NOTICE THAT THE HOSE ASSEMBLY STARTED LEAKING, WHEN WIGGLED IT SLIGHTLY THE HOSE ASSEMBLY HAD FAILED, AND STEAM LEAKED ON THE TECHNICIAN FOREHEAD. TECHNICIAN WENT TO THE ER TO TREAT THE BURN. THE BURN WAS CLASSIFIED ACCORDING TO TECHNICIAN AS 2ND DEGREE BURN. WE DECIDED TO REPORT THE ISSUE BASED ON EVENT THAT LED TO SERIOUS INJURY. GETINGE TECHNICIAN ORDER NEW HOSE AND FINALIZED THE REPAIR ON 4TH OCTOBER 2024. THE UNIT WAS TESTED AND RETURNED TO CUSTOMER.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.