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

Model Number 8668

Device Problems Failure to Disinfect (1175); No Flow (2991); Suction Failure (4039)

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 pipe between the enzyme`s container and the peristaltic pump was disconnected, causing the failure of adding the enzyme.There was no alarm on the device.We confirm that the customer found the problem during the daily inspection.However, we could not confirm that the regular checks of the processed loads were carried out.There was no injury reported, however we decided to report the issue based on the potential as non-properly cleaned goods could be used to patient treatment and could be a source of cross-infection.

Manufacturer Narrative

Additional information will be provided following conlusion 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 reference number: (b)(4).

Manufacturer Narrative

On 22nd october 2021, getinge became aware of an issue with 8668 washer-disinfector with the catalog number s-86682003-ctom and the serial number (b)(6), manufactured on 16th january 2014.As it was stated, during the daily inspection the customer found out that the unit is not dosing the enzyme.Getinge clean enzymatic detergent is dedicated for general cleaning of surgical instruments and utensils.It is used with automated washers and designed to penetrates and breaks down protein and organic matter.As it was stated there were no visual checks performed on each load and the customer did not perform additional load testing.According to user manual it is recommended to visually inspect the items after unloading.With the complaint at hand there was no allegation about any adverse outcome, however we decided to report the issue based on the potential, that any improper cleaned instruments, as a result of detergents not dosed correctly during the process, could be used to the patients¿ treatment and lead to the cross-infection.During investigation course it was confirmed that the pipe between the enzyme`s container and the peristaltic pump was disconnected, causing the failure of adding the enzyme.After the pipe was replaced by service technician the device was returned to use in full operational state.Based on the information gathered the pipe could have failed as a result of expected wear and tear or it could have been artificially damaged during enzyme replacement.However further in the investigation course it was establish that the device¿s service manual is instructing the service technician what actions should be taken during the preventive maintenance, and most likely the preventive maintenance schedule wasn¿t followed, preventive maintenance was performed by service technician not in line with instructions given as part of the service manual.The hose was not replaced as required during preventive maintenance.This is why the most likely root cause in this particular case has been established as service issue.It was confirmed that when the event occurred, the device was directly involved and did not meet its specification, as pipe between the enzyme`s container and the peristaltic pump was disconnected and the detergent was not dosed.We have not received information whether the device was being used for patient treatment or diagnosis at the time when the event occurred.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)(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: 12787153
• MDR Text Key: 285010365
• Report Number: 9616031-2021-00035
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1