MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 122; STERILIZER, STEAM

Model Number 122

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.H3 other text : device not returned to the manufacturer.

Event Description

On 19th september, 2019 getinge became aware about an issue with 122hc steam sterilizer.As it was stated by the customer, blue instrument wrap, autoclave bottle caps and stoppers were disintegrating in the device after the cycle.During the inspection it was found that customer was being used the signle use wraps, caps and stppers more time than one.Moreover, it was noted that customer was occasionally leaving loads in the device over night or over the weekend.There was no injury reported and no malfunction on the device observed, however it was decided to report this issue in abundance of caution, as incorrectly prepared load for sterilization and stored after the process could be used on the patient treatment leading to contamination.

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

Getinge became aware about an issue with 122hc steam sterilizer.As it was stated by the customer, blue instrument wrap, autoclave bottle caps and stoppers were disintegrating in the device after the cycle.During the inspection it was found that customer was using the single use wraps, caps and stoppers more times than once.Moreover, it was noted that customer was occasionally leaving loads in the device over night or over the weekend.There was no injury reported and no malfunction on the device observed, however it was decided to report this issue in abundance of caution, as incorrectly prepared load for sterilization and stored after the process could be used on the patient treatment leading to contamination.It was established that when the event occurred, the sterilizer did not meet its specification and it contributed to the event.The device was not being used for patient treatment.The most likely root cause is improper load preparation by the user.It is clearly stated in the instructions for use that wraps are not reusable.With regards to rubber stoppers and caps, they are re-usable but over time will harden and should be scrapped.It is worth to be noted that both those accessories are not labeled as getinge.The sterilizer itself has checked by the company representative and no technical malfunction was found.We also believe that if the labeling recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that this is the 1st complaint of this nature on this device type (discontinued) we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: 122
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 9109729
• MDR Text Key: 216934640
• Report Number: 3012068831-2019-00012
• 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: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 122
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1