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

Model Number 8666

Device Problem Fluid/Blood Leak (1250)

Patient Problem Bruise/Contusion (1754)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 23th august, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8666.The event took place on 22nd august, 2022.As it was stated, there was leak from under the unit.The operator slipped on small puddle of water and fell.The fell led to the bruise on the inside part of the right knee and left buttock.The accident report states that the injured operator felt better after few minutes.There was no medical treatment needed.We decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contributed to the serious injury if recur.

Manufacturer Narrative

On 23th august, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8666, serial number: (b)(6) and catalog number s-8666913-ctom.The device was manufactured on 19th october, 2009 and installed on 8th june ,2010.Preventative maintenance on this washer is being performed under getinge service agreement with the customer.Last preventive maintenance, before the investigated event was performed on 31st march, 2022.The device passed all tests , there were no signs of a malfunctioning, such as e.G.Water leaks.As it was stated, there was a water leak from the unit.The leaks on the device were found and the issue was solved by tightened circulation pump hose clamps.We established that the leakage from the untightened hoses directly contributed to the adverse event, which took place on 22nd august, 2022.The operator slipped on small puddle of water and fell.The fall led to a bruise on the inside part of the right knee and the left buttock.The accident report states that the injured operator felt better after few minutes.Therefore we decided to report the case in abundance of caution as this kind of malfunction could lead to serious injury.As a result of performed investigation it was not possible to establish the most probable root cause of the event.Several possible scenarios were listed, but despite our best investigative efforts it is not possible to determine with certainty a specific root cause of the problem.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but given the low level of occurrence, did not provide any signals that triggered further scrutiny.It was established that the getinge product was directly involved with the reported event.A getinge service technician visited the customer site, inspected the device, investigated the problem, and adjusted the hose clamps as a precaution.The device was tested and returned for use in a fully operational state.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.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 for any further events of this nature.

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: 15310064
• MDR Text Key: 303404470
• Report Number: 9616031-2022-00019
• 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
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male