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 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 27th august, 2019 getinge became aware with an issue with one of the washer/disinfectors, 88-series.As it was stated, the detergents (alkali and rinse) was mixed on the device and used in this state in between (b)(6) and (b)(6) 2019.There was no adverse outcome reported, however the mixed detergents could have had impact on the process effectiveness and the loads could be non-appropriately disinfected.Therefore we decided to report the complaint based on the potential.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find total of 4 reportable complaints for mixed detergents on 88-5 devices, reported to company¿s complaint handling system within last 5 years.When the event occurred, the device likely did not meet its specification as due to the mixed detergent hoses the cleaning and disinfecting process could have been affected.There was however no actual technical malfunction found within the main device.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2015, type 88-5 washer disinfector.During the investigation course, we were able to establish that the rinse and alkaline detergents were mixed in the device.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 first solve the problem by placing hoses in correct detergent bottles and afterwards, performed a retraining of the customer personnel in regards user manual content and correct replacement activities.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: 9621565
• MDR Text Key: 200050441
• Report Number: 9616031-2020-00003
• 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
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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: No Information
• Device Model Number: 88-5
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1