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

Model Number 88-5

Device Problems Insufficient Flow or Under Infusion (2182); Chemical Problem (2893); Device Handling Problem (3265)

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

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of the washer-disinfectors, 88-5.As it was stated, the customer noticed error related to the detergent flow on the machine.The error occurred due to the detergent pump motor malfunction.During the troubleshooting the technician found mixed detergent hoses (resulting of pumping the lubricant instead of enzyme).We were not able to establish for how long the detergents dosing was incorrect and if the loads affected was used.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 cleaning process and the uncleaned good may have been used to the patients¿ treatment.

Event Description

Manufacturer reference number (b)(4).

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 did not meet its specification as due to the mixed detergent hoses the cleaning and disinfecting process could have been affected.Moreover the detergent pump malfunction occurred, most likely related to the prolonged use of the device and normal ware of this part.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2011, type 88-5 washer disinfector.During the investigation course, we were able to establish that the enzyme and lubricant detergents were mixed in the device.This happened most likely 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 replace the detergent pump motor and then place the hoses in correct detergent bottles.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: 88-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 10129183
• MDR Text Key: 196912063
• Report Number: 9616031-2020-00021
• 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
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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
• Device Catalogue Number: 88-303-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1