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

Model Number 8668

Device Problems Failure to Disinfect (1175); Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

On 22nd october 2021, getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668.As it was stated, the customer reported that the unit is not dosing the detergent.During the getinge technician service of the device it was confirmed that detergent pump failed.The detergent pump and squeeze tube have been replaced.Proper function of enzyme was verified.The device was returned to use in full operational state.Gathered information allowed us to establish that during this event no alarm occurred on the device and no flowmeter was installed.We could not confirm how long the enzymatic detergent was not pumped during the cycles and we have not received confirmation whether the regular visual checks after each processed loads were carried out.So far, we have not been informed of any adverse consequences related to this issue.Based on the all information collected, we decided to report this customer product complaint in abundance of caution and based on the potential that any ineffective cleaned goods could be used to the patients¿ treatment and could be the source of cross-infection.

Manufacturer Narrative

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

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide a correction of the field #h4.Device manufacture date: previous device manufacture date: 2008-09-18, corrected device manufacture date: 2008-09-04.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On october 22nd, 2021, getinge became aware of an issue with washer disinfector model name 8668 with serial number (b)(6) and catalog number s-86682003-ctom.The device was manufactured on 4th september 2008 and it was installed at the facility on (b)(6) 2009.Preventative maintenance on this washer is being performed under getinge service agreement with the customer.As it was stated in complaint record the enzymatic detergent was not dispensed to the chamber in correct amount during process.This issue was discovered by employee during daily inspection of detergent level in detergent container.It was impossible to confirm how long the issue with detergent dosing was present on the device.We are not aware of any adverse event in relation to the incident, however we decided to report the issue based on the potential that any non-properly cleaned goods may have been used for the patient treatment and may have become a source of cross-infection.During initial inspection getinge technician detected that detergent pump was inoperative.He has replaced faulty detergent pump with a new item, tested operation of all pumps installed on the device, evaluated as satisfactory and put the device back in service.The review of reportable events registered for 86-series devices manufactured by getinge disinfection ab reported to company¿s complaint handling system within last 5 years was performed.It revealed that the complaint is one of several reported cases related to possible incorrect detergent dosing, however it is not a part of increasing trend and compared to the number of devices available on the market according to install base, failure rate is very low.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.Review of reported events revealed that in the past the reported scenario has never led to serious injury.During the investigation course we were able to establish that the device, which was directly involved in the reported event was not equipped with flow meter.Flow monitoring system is an optional system and it does not come as standard with the machine.It can be installed on the machine on customer request.The malfunction of detergent pump would have been detected if a flow meter had been installed one the device.As the pump was more than 10 years old and have lived past its life time expectancy most probably this particular issue is related to expected wear and tear.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature, we shall continue to monitor the customer experiences with the devices 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: 12834632
• MDR Text Key: 282273043
• Report Number: 9616031-2021-00036
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1