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

Model Number 8666

Device Problems Failure to Disinfect (1175); Leak/Splash (1354); Failure to Pump (1502); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 getinge became aware of an issue with the 86-series washer disinfector with the model name 8666.As it was stated the water and the washing detergent were leaking out of detergent pump cover.The leakage was greatest in the washing phase.Tha gathered information provides that the customer was using the washer disinfector despite the sever leakage.We also do not have any information if and how often the user checks the cycle results.During the troubleshooting the unit was repaired and returned to the service.There was no injury or damage 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

Additional information will be provided following 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.

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On november 29th, 2021, getinge became aware of an issue with washer disinfector model name 8666 with serial number (b)(6) and catalog number s-8666913-ctom.The device was manufactured on november 29th, 2010 and it was installed at the facility on december 08th, 2011.As it was stated in complaint record, the washing detergent and water was leaking out of the detergent pump cover.The customer is using one of washing detergents neutrawash plus or tec wash iii, which are used to provide effective cleaning during washing phase.The gathered information provides that the issue could cause incorrect dosing of washing detergent during the process and the customer was using the washer disinfector despite the severe leakage.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 tubing was worn and he has replaced defective squeeze tubes in all three pumps on the device.He has tested the operation of the pumps, 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 was performed.We were able to establish that this is one of several reported cases related to possible incorrect washing detergent dosing on this type of devices reported within the last 5 years and it is not a part of increasing trend.At the time of the event occurrence the unit was directly involved and failed to meet its specifications.However, 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 performed investigation it was established that expected wear and tear occur naturally during normal operation and indicate that the squeeze tube is no longer functioning according to specification.According to the manual preventive maintenance on dosing system has to be performed yearly, including checking of detergent tubing, which should be replaced if it is required.Unfortunately, manufacturer could not conduct the technical investigation and determine the root cause without requested information.However, in case of new relevant information, the case will be reconsidered.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.The purpose of this submission is also to provide a correction of h4.Device manufacture date this is based on the result of the review noting the initial report was incorrectly submitted stating another manufacture date.#h4 previous device manufacture date#: 2010-12-21.Corrected device manufacture date#: 2010-11-29.

Event Description

Manufacturer's reference number:(b)(4).

• 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: 13059551
• MDR Text Key: 282611515
• Report Number: 9616031-2021-00040
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1