MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 500-SERIES; STERILIZER, STEAM

Model Number 533HC-E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 getinge became aware about an issue with one steam sterilizer: 522hc-e.As it was stated, the steam leaked through the door seal into the room.There was no injury reported and no information how big the leak was were provided.However, taking under consideration the worse case scenario that any unexpected steam leak from parts available to the customer might lead to an adverse event, it was decided to report this issue based on the potential.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

On 25th june, 2019 getinge became aware about an issue with one steam sterilizer: 533hc-e.As it was stated, the steam leaked through the door seal into the room.There was no injury reported and no information how big the leak was were provided.However, taking under consideration the worst case scenario that any unexpected steam leak from parts available to the customer might lead to an adverse event, it was decided to report this issue based on the potential.

Manufacturer Narrative

Getinge became informed of an issue with a steam sterilizer 533hc-e device with serial number (b)(6) that was described by customer as steam blowing from the device¿s door.With the limited information received we were not able to determine when exactly the steam leak occurred and how strong it was.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 15th december 2015.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.Last pm before the event was performed in (b)(6) 2019.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 damaged door gasket.As for what caused the damage, it appears the most likely cause relates to preventive maintenance instruction not being followed.According to manuals and service history preventive maintenances the door gasket has not been replaced in last 6 months.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 model # sections.This is based on the result of an internal review noting the report was incorrectly submitted stating another model name.#b5: previous describe event or problem: on (b)(6) 2019 getinge became aware about an issue with one steam sterilizer: 522hc-e.As it was stated, the steam leaked through the door seal into the room.There was no injury reported and no information how big the leak was were provided.However, taking under consideration the worst case scenario that any unexpected steam leak from parts available to the customer might lead to an adverse event, it was decided to report this issue based on the potential.Corrected describe event or problem: on 25th june, 2019 getinge became aware about an issue with one steam sterilizer: 533hc-e.As it was stated, the steam leaked through the door seal into the room.There was no injury reported and no information how big the leak was were provided.However, taking under consideration the worst case scenario that any unexpected steam leak from parts available to the customer might lead to an adverse event, it was decided to report this issue based on the potential.#d4: previous model #: 522hc-e.Corrected model #: 533hc-e.

• Brand Name: 500-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 8774950
• MDR Text Key: 204067201
• Report Number: 3012068831-2019-00005
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 533HC-E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1