MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Device Unsafe to Use in Environment (2918); Environmental Compatibility Problem (2929); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/19/2018

Event Type  Death  

Manufacturer Narrative

During a preventative maintenance visit to this facility, medivators field service engineer was informed that the facility's water supply had been contaminated by legionella bacterium and patients had been infected.The medivators field service engineer (fse) was onsite the day after the bacteria was discovered by the facility.There was limited information provided about the extent of the contamination.After additional ra investigation, it was reported that 14 patients had become infected and 3 of these 14 had died.The facility also reported the cause of the bacteria was potentially from a reduced hot water supply which allowed the bacteria to grow.There is no information that the medivators automated endoscope reprocessors (aer) at this facility being contaminated by the legionella bacterium.There is no information on how the bacteria reached the patients.Medivators fse advised that all aers should have all filters replaced and they should run a water line disinfection cycle on each before reprocessing endoscopes.The facility completed these actions as well as flushing chlorine through the water pipes to eliminate the bacteria.It was reported that all infected patients were admitted for serious health conditions.It was not confirmed that the cause of death was due to the bacterium or because of other health issues.There are no reports that the infected patients got this bacterium from endoscopy related procedures; thus, there is no information that medivators aers or other products were the source of this contamination.This will continue to be monitored in the medivators complaint handling system.

Event Description

During a preventative maintenance visit to this facility, medivators field service engineer was informed that the facility's water supply had been contaminated by legionella bacterium and patients had been infected.

Manufacturer Narrative

After additional investigation consulting with medivators internal microbiology and technical experts, the legionella bacterium would have been removed from the water in the dsd edge aer by the.2 micron absolute bacteria retentive filter.The high performance 0.2-micron water filter included with the reprocessor is a bacterial-retentive filter that removes all microorganisms and particles greater than 0.2-micron.The.2 micron is last filter that water passes through before entering the basin or hookup channels.Legionella cells measure 0.3-0.9 micrometers by 2.0-3.0 micrometers according to the world health organization, so these organisms would be captured in the.2 micron filter.The cdc (centers for disease control) recommends using a 0.2 micron filter to extract legionella bacterium from potable water.Medivators routine maintenance schedule recommends replacing the 0.2-micron water filter every 6 months or sooner, depending on the pre-filtration system and the quality of the incoming water.If either the 1 micron or.45 micron filters in the prefiltration system or the.2 micron filter in the machine gets congested, a low fluid flow alarm would alert the user of necessary filter replacement.Additional information has also been provided by medivators technical service engineer that has been onsite performing routine maintenance activities.It was reported that all facility water supplies had been turned off to the aer machines with notes physically on them not to run until ok from facilities management.The fse did not run water during the repair.The water filters to each machine in area were up to date according to their filter replacement log.The filter changes and the filter replacement log are reported to be maintained by their facilities maintenance.It was also reported by the fse that after the "ok" from facilities to run water and after completing the repair, the fse ran a water-by-pass for 1 hour to flush house chlorine flash before testing machine.Confirmed the repair fixed the issue and all test cycles passed.The fse recommended the facilities department lead that each machine needs a 2 hour wld before scopes can be reprocessed.It is unknown if water line disinfection cycles were run after the facilities water was running.There was limited information provided.It was not disclosed how the patients specifically were infected nor was further information provided regarding the patient deaths.The cause for the bacterial growth was reported to be from a reduced hot water supply which allowed the bacteria to grow.It has been confirmed by internal investigation that the events in this medical device report are not caused by the medivators aer device.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 8210296
• MDR Text Key: 131852141
• Report Number: 2150060-2019-00002
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death