MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 88-5

Device Problems Failure to Disinfect (1175); Chemical Problem (2893)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 21st october, 2019 getinge became aware of an issue with 88-5 washer disinfector.As it was stated, the rinse and alkaline detergents were mixed 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 still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

The issue is still 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 establish that the received incident is the second one registered for the issue of unintended and unnoticed mixed detergents on 88-5 devices.When the incident occurred, the device was directly involved.The device did meet its specification.Upon the event occurrence the device was not being used for patient treatment or diagnosis.The device affected is the 88-5 washer disinfector, manufactured on 14 october, 2014.During the investigation course, we were able to establish that the rinse and alkaline detergents were mixed in the device.According to the subject matter experts of the manufacturer, this appears to have happened due to user error, where the user put the dosing hoses to the wrong detergent bottles.In the user manual (001234702 rev.J) it is clearly explained how to change the detergents and put the hoses in the right detergent bottles.If the user would follow the ifu, there would be no risk of mixing detergents resulting in loads could not be cleaned properly.From our evaluation of the 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.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 88-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9223706
• MDR Text Key: 200048217
• Report Number: 9616031-2019-00031
• 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,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2020

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: 88-5
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 12/02/2019; 01/13/2020
• Supplement Dates FDA Received: 11/15/2019; 12/30/2019; 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1