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

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  Injury  

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 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
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7894205
• MDR Text Key: 120875592
• Report Number: 2150060-2018-00064
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other