MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 8666

Device Problems Chemical Problem (2893); Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 getinge became aware of an issue with 8666 washer disinfector.As it was stated, the neutralizer and lubricant detergents were switched in the device.There was no injury reported however we decided to report the issue based on the potential as the issue may affect the final result of the process.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find a total of 3 related complaints for mixed detergents on 86-series devices, reported to getinge within last 5 years.When the event occurred, the device likely did not meet its specification in the sense that due to the mixed detergent hoses the cleaning and disinfecting process could have been affected.However none of the actual technical malfunction found within the main device has an impact to the cleaning process effectiveness.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2005, type 8666 washer disinfector.During the investigation course, we were able to establish that the device failed the tosi test.When the technician arrived on site, he detected several malfunctions on the device, such as: missing parts on the spray arms, broken dryer fan, wrong set temperature in the cycle phases and the switched detergent hoses.It was established, that from all those issues, the switched detergents was what could be the cause of cleaning process ineffectiveness resulting in the tosi test failure.This happened due to user error, which took place while changing the detergents and because of the dosing hoses being put to the wrong detergent bottles.It appears that the activity was performed in a way that is not in line with information and instruction available in the product user manual.Due to this fact, the technician was able to solve the problem by placing hoses in correct detergent bottles.The other issues on the machine were found to be related with a normal wear and tear of the device and the incorrect software settings performed by the user.All the issues were solved by the technicians¿ activities, including the parts replacement and adjusting the software settings.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.

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9240085
• MDR Text Key: 195577781
• Report Number: 9616031-2019-00032
• Device Sequence Number: 1
• Product Code: MEC
• 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: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8666
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 12/06/2019; 03/18/2020
• Supplement Dates FDA Received: 11/19/2019; 12/30/2019; 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1