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

Model Number 8668T

Device Problem Failure to Clean Adequately (4048)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2021 getinge became aware of an event related to 86-series washer disinfectors used together with the getinge clean management system (cms).Received allegation was pointing to goods not being clean after the process.It was stated that this happened probably due to the foaming of the chemicals used during the pretreatment that prevented an enzyme agent from the efficient cleaning.The problem was detected by the customer as they perform visual check of instruments after each load before placing it in the autoclave, as recommended by the manufacturer in the user manual.However, we also received confirmation that due to the situation described the instruments were not available to be used during the life saving thorax surgery.Till the date we do not have any information about the adverse outcome for the patient, however we decided to report the customer product complaint to the competent authority based on a risk related to the delay in the above described procedure and the potential for its adverse consequences.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide a correction of #h4 device manufacture date.This is based on the result of an internal review noting the initial report was incorrectly submitted stating another device manufacture date.H4: previous device manufacture date #: 2020-02-20.Corrected device manufacture date #: 2020-01-28.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 19th of october 2021, getinge became aware of issue related to 86-series washer disinfectors used together with the getinge clean management system (cms).The issue is described as being related to 6 washer disinfector (86-series with the serial numbers (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6)) that were connected to clean management system (cms sn (b)(6)).Based on the information provided by the technician the event occurred on the one of the washer disinfector 8668t with the serial number (b)(6), udi number (b)(4) manufactured on 21st jan 2020 and installed on 1st march 2020.As it was noticed by the customer the goods were not clean after the automated cleaning and disinfection process performed in the washer disinfector.It was stated that this happened probably due to the pre treatment foam remaining on the instruments and made it impossible that the enzyme agent cleaning effectively.The getinge pre treatment foam is designed to keep soil moist on medical devices prior to reprocessing and is used in preparation phase prior to placing the load in the washer for cleaning process.The service technician during the visit has not confirmed that the fact that goods were not clean after the automated cleaning and disinfection process, was related to the failure of the washer disinfector or a deviation in formulation of the getinge clean enzymatic detergent.As it was confirmed by subject matter expert during the investigation, the user is instructed to remove any pre treatment foam before the wash phase, failure to do so can result in pre treatment foam remaining on the instrument as alleged in this customer product complaint.The result of the investigation allows us to conclude that the most likely root cause of the issue can be defined as the user error.To prevent such situation the customer is to be reminded about the content of the user manual ¿6002009402_user_86-series_revh¿ for 86-series washer disinfectors, which states how to prepare the goods before to place it in to washer disinfector.It was confirmed that when the event occurred, the device was directly involved and did not meet its specification, as goods did not become cleaned.The situation led to a delay in treatment.The device was not being used for treatment or diagnosis of the patient.We were not informed of any serious injury or worse as a result of the event.However, we reported the event based on information that the issue have caused delay in treatment as the instruments were not timely delivered to thorax surgery.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
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 12752415
• MDR Text Key: 280156599
• Report Number: 9616031-2021-00033
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1