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

Model Number 8666

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

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2nd august 2021, getinge became aware of an issue with one of the washer-disinfectors with the model name: 8666.As it was stated, the enzymatic detergent was not pumped to the washer disinfector.We could not confirm how long the enzymatic detergent was not pumped during the cycles and we have not received confirmation whether 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.

Event Description

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

Manufacturer Narrative

Additional information will be provided following conclusion of the investigation.

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

According to the reporting time frame 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).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On august 2nd, 2021 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8666, with the catalog number s-8666913-ctom and the serial number (b)(6).The unit was manufactured on 10th march 2015.The reported issue is related to the enzymatic detergent dosing issue that could lead to ineffective cleaning of the goods.We were able to establish that this is the 11th reportable customer product complaint related to the issue involved on this type of devices reported within the last 5 years.The customer allegation was that the enzymatic and lubricating detergent was not pumped to the washer and this malfunction has been found after some time.The getinge service technician visited the site and confirmed that the enzyme and lubricant of the washing machine could not have entered the cavity through the peristaltic pump.The nut on the pump rotating arm was dropped and lost, therefore the pump did not turn on when it was energized.The malfunctioning pump and squeeze tubes have been replaced.The device was returned to customer use in fully operational state.Gathered information allowed us to establish that during this event no alarm occurred on the device and no flowmeter was installed, which would issue a warning that the detergent flow between the container and the chamber is too low.Moreover, we have not received confirmation whether the regular checks of the processed loads were carried out.Therefore, the failure of enzymatic detergent dosing could lead to undetected failed cleaning.Potential cause of the failure could be related to not following the instructions regards performing of preventive maintenance activities, which could result in pump malfunction, damage or incorrect dosing.However, the technical investigation could not be performed without the full documented history of the preventive maintenance, therefore the exact root cause of the issue cannot be determined.It was confirmed that when the event occurred, the device was directly involved and did not meet its specification, as the enzymatic and lubricating detergents were not dosed properly to the chamber.The situation can lead to the improperly cleaned instruments despite completed process.The device was not being used for treatment or diagnosis of the patient.We are not aware if the described issue caused or contributed to the serious injury or worse, however we report the event based on the potential that any ineffective cleaned goods could be used to the patients¿ treatment and could be the source of cross-infection.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: 12365420
• MDR Text Key: 268063706
• Report Number: 9616031-2021-00025
• 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,Followup,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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: 04/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1