MAUDE Adverse Event Report: MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators field service engineer (fse) reported while on site at a facility servicing their dsd-201 automated endoscope reprocessor (aer) that one basin of the aer had the incorrect temperature settings per the rapicide high-level disinfectant being used.There is potential that endoscopes reprocessed in the aer were not adequately high-level disinfected, thus there is potential for patient harm.The facility uses rapicide high level disinfectant in their aer which requires a 5-minute minimum contact time at 35°c.The facility's aer was set to 20°c.While onsite, medivators fse observed a cycle printout showing an endoscope was reprocessed at 27°c.Facility staff were informed of the fse's findings and it was reported that the endoscope reprocessed at 27°c was manually high-level disinfected afterwards.Medivators fse corrected the temperature setting and recommended the facility review their cycle reports to check if other endoscopes were reprocessed at temperatures below the minimum requirement of 35°c.Per the medivators dsd-201 user manual, users are required to verify correct parameter settings are appropriate for the type of hld utilized.No information was provided to medivators regarding how many cycles may have been affected.Medivators fse also reported during his service visit that the facility had installed the water filters in their aer incorrectly.They had placed the 0.45 micron filter before the 1.0 micron filter.Facility staff were informed and medivators fse correctly installed new filters for the facility.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
Medivators field service engineer reported while on site at a facility servicing their dsd-201 automated endoscope reprocessor that one basin of the aer had the incorrect temperature settings per the rapicide high-level disinfectant being used.There is potential that endoscopes reprocessed in the aer were not adequately high-level disinfected, thus there is potential for patient harm.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7894205
• Report Number: 2150060-2018-00064
• Device Sequence Number: 13937921
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other