MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 400-SERIES; STERILIZER, STEAM

Model Number 433HC

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6), 2021 getting became aware of the positive biological test after standard sterilization cycle on 433hc device.Getting technician has stated that the affected items were to be reprocessed but before biological test result was complete, the surgical staff had used one of the instruments during a procedure.Our technician has been informed that the facility infection control staff are following up on the situation.Getting employee has inspected the device involved and was not able to determine any device malfunction.The initial inspection found that the device was recently maintained and main component are intact.The leak test was performed by the getting technician and it was passed.Additionally, the standard cycle was run with instrument load and two biological test packs.The test was passed.Unit was returned to service at discretion of department.With the information received to date, we conclude that the getting device did not directly cause any harm, however it may have contributed to the adverse outcome as unsterilized goods were used for the patient treatment.Therefore, we decided to report this case to competent authorities in abundance of caution.

Manufacturer Narrative

Getinge became aware of a positive biological test after standard sterilization cycle on 433hc device, and the subsequent use of the involved instruments; a getinge technician has stated that the affected items were to be reprocessed but before biological test result was complete, the surgical staff had used one of the instruments during a procedure.Our technician has been informed that the facility infection control staff are following up on the situation.At the closing of the investigation, no adverse outcome on a patient was reported to getinge.Getinge employee has inspected the device involved and was not able to determine any device malfunction.The initial inspection found that the device was recently maintained and main components are intact.The leak test was performed by the getinge technician and it was passed.Additionally, a standard cycle was run with instrument load and two biological test packs.The test was passed.Unit was returned to service at discretion of department.We have received also an information that in the cycle where biological test was positive, a 3m brand steam integrator was used and it passed for this load.With the information received to date, we conclude that the getinge device did not directly cause any harm, however it may have contributed to the adverse outcome as unsterilized goods were used for the patient treatment.Therefore, we decided to report this case to competent authorities in abundance of caution.When reviewing reportable events for this type of issues we were able to establish that the received incident is the first one registered in getinge complaint handling systems of its kind.Fortunately, the event has not led to serious injury or worse.When the event occurred, the device did meet its specification however it contributed to the event.The device was not directly being used for patient treatment when the event took place.Based on the performed root cause analysis we conclude that the device operator did not wait for biological indicator result, before using the device load (surgical instruments).User manual refers to aami standard st79: comprehensive guide to steam sterilization and sterility assurance in health care facilities where information about using biological indicators are provided.We currently do not have any information that would warrant further action towards the devices, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The purpose of this submission is also to provide a correction of section usage of device #h8: previous answer: initial use of device corrected answer: reuse.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 400-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 11746639
• MDR Text Key: 257207599
• Report Number: 3012068831-2021-00002
• 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
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 433HC
• Device Catalogue Number: 4SSVUPHRAAAA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other