MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 800-SERIES; STERILIZER, STEAM

Model Number 833HC-E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by the manufacturing site.Device not returned to manufacturer.

Event Description

On 15th january, 2020 getinge became aware of an issue with sterilizer ¿ 833hc.As it was stated, unit ejected steam from door area upon starting the cycle and it set off the facility fire alarm.There was no injury reported however we decided to report the issue in abundance of caution as any severe steam leak from door area once the chamber is pressurized might bring on a hazardous situation for the user.

Manufacturer Narrative

Getinge became informed of an issue with a steam sterilizer 833hc-e device with serial number (b)(4).As it was stated, the unit ejected steam from door area upon starting the cycle and it set off the facility fire alarm.There wasn't any injury reported due to this case, however we decided to report this case in abundance of caution as any unexpected steam leak under the pressure and from parts facing the customer might lead to an adverse event.It was decided to report this issue based on the potential related to worst case scenario.When reviewing reportable events for this type of issues we were able to find several similar complaints where the steam has blown from door area at the various reasons.Fortunately the event has not led to serious injury or worse.The device was manufactured on 29th december 2015 and installed on the 16th february, 2016.The dhr for the device was reviewed and no related anomalies were found.The device was released to the customer in a fully working condition.Preventive maintenance (pm) is being performed under getinge agreement.When the event occurred, the device did not meet its specification and it contributed to event.The provided information did not indicate that the device was being used for patient treatment when the event took place.Based on performed root cause analysis we conclude that the steam blowing from door sterilizer was caused by double failure of two components: steam to gasket valve that allows steam to enter the gasket line and seal the door and pressure switch that informs control system about door seal status.Getinge has received no information whether door sealing/unsealing issues happened on this unit in the past due to cold start performed to determine if user error has led to described issue.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.Corrected data: the purpose of this submission is solely to provide a correction of model name included in describe event or problem and version or model # sections.This is based on the result of device history record review noting the report was incorrectly submitted stating another model name.Event description: previous describe event or problem: on 15th january, 2020 getinge became aware of an issue with sterilizer ¿ 833hc.As it was stated, unit ejected steam from door area upon starting the cycle and it set off the facility fire alarm.There was no injury reported however we decided to report the issue in abundance of caution as any severe steam leak from door area once the chamber is pressurized might bring on a hazardous situation for the user.Corrected describe event or problem: on 15th january, 2020 getinge became aware of an issue with sterilizer ¿ 833hc-e.As it was stated, unit ejected steam from door area upon starting the cycle and it set off the facility fire alarm.There was no injury reported however we decided to report the issue in abundance of caution as any severe steam leak from door area once the chamber is pressurized might bring on a hazardous situation for the user.Previous version or model #: 833hc.Corrected version or model #: 833hc-e.

Event Description

On 15th january, 2020 getinge became aware of an issue with sterilizer ¿ 833hc-e.As it was stated, unit ejected steam from door area upon starting the cycle and it set off the facility fire alarm.There was no injury reported however we decided to report the issue in abundance of caution as any severe steam leak from door area once the chamber is pressurized might bring on a hazardous situation for the user.

Manufacturer Narrative

Additional information is provided to previous emdr follow up report #1 due to investigation update.After the issue occurrence, the device was inspected by getinge technician.Several waterlogged components of 833hc-e device with serial number (b)(6) needed replacement to get the unit back in operation: display panel, power supply and control box.The getinge service technician confirmed that the damage of those components was caused by the facility sprinklers activation.The issue was initially determined to be caused by the double failure of steam to gasket valve and gasket pressure switch.The steam to gasket valve allows steam to enter the gasket line and thereby seals the door.The pressure switch informs the device¿s control system of the door seal status.However, after further analysis it was determined that the most probable cause of the malfunction was failure of steam to gasket valve and gasket retract valve.In the first report from service representative manufacturer was informed that the pressure switch and door gasket retract valve needs replacement.During first visit steam to gasket valve was replaced.During second visit getinge technician replaced gasket retract valve and door gasket that was damaged due to the valve malfunction ¿ door movement with gasket not fully retracted caused gasket damage.It has been determined that the event occurred most probable due to failure of two valves: steam to gasket and gasket retract valve.Gasket retract valve opens in order to remove the steam pressure from gasket line, allowing gasket to return to position that door moves freely.After technician¿s second visit the unit was restored to service.The reason of this occurrence was determined to be related to a failure of the door function, namely the door not sealing properly before the cycle started.The unexpected loss of door function resulted in the event described.Based on analysis of device complaint files, the most probably root cause has been determined.The conclusion is that event occurred due to failure of steam to gasket and gasket retract valves.Based on the investigation conclusions and the fact that the device is under getinge service agreement the manufacturer does not recommend any additional actions at this point.The potential risk has been considered as a low due to the fact that design of paneling directs any uncontrolled release of steam to the sides and back away from the user.History of complaints shows that there was no injury related to the steam leak from the door area.The purpose of this submission is also to provide a correction of: event problem and evaluation codes (evaluation result codes).This is based on the result of updated investigation due to additional information.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 800-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 9621570
• MDR Text Key: 195025086
• Report Number: 3012068831-2020-00001
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 833HC-E
• Device Catalogue Number: 8MRVUTHPAAAA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1