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

Model Number 88-5

Device Problem Chemical Problem (2893)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

Event Description

On 19th october 2020, getinge became aware of an issue with one of the washer disinfectors: 88-5 device.The first customer allegation was that the unit failed tosi test.When the technician arrived on site, he found lube and enzyme detergents mixed on the device.Also the technician found the detergent tube squeezed.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 have negative impact at the final result of the cleaning process and the uncleaned goods may have been used to the patients¿ treatment.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find that the issue of mixed detergents on 88-5 devices, as reported to company¿s complaint handling system within last 5 years does not represent an upward trend in occurrences and only represents a very low ratio of events per device.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 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 appears to have taken 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 place the hoses in correct detergent bottles and then label the hoses and containers to avoid such a mistakes in the future.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)(6).

• Brand Name: 88-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• MDR Report Key: 10835649
• MDR Text Key: 216336486
• Report Number: 9616031-2020-00040
• 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: 12/07/2020

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: 10/19/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1