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

Model Number DSD-201

Device Problem Pressure Problem (3012)

Patient Problem Chemical Exposure (2570)

Event Date 12/31/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The facility reported residuals left on a duodenoscope after reprocessing in a medivators dsd-201 automated endoscope reprocessor (aer).The facility has had issues maintaining the appropriate incoming water pressure for their two dsd-201 aers.If endoscopes are not properly rinsed, there is potential for patient and/or handler residual disinfectant exposure.Medivators field service engineer (fse) visited the facility to check the operation of their dsd-201 aers.Both were operating to specification.The fse observed that when both aers were running at the same time, the incoming water pressure fell below the minimum recommended pressure.The fse advised the facility to install a booster pump to help maintain the appropriate water pressure.The facility is currently testing various options to resolve the pressure issues.If the appropriate dsd-201 fluid flow parameters are not met, the aers will alarm.To date, there have been no known reports of patient or handler exposure symptoms or additional reports of scopes with residuals at the facility.This complaint will continue to be monitored by the medivators complaint handling system.

Event Description

The facility reported residuals left on a duodenoscope after reprocessing in a medivators dsd-201 automated endoscope reprocessor (aer).The facility has had issues maintaining the appropriate incoming water pressure for their two dsd-201 aers.If endoscopes are not properly rinsed, there is potential for patient and/or handler residual disinfectant exposure.

• 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5400145
• MDR Text Key: 37178989
• Report Number: 2150060-2016-00004
• Device Sequence Number: 1
• Product Code: FEB
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/29/2016

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
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/31/2015
• Initial Date FDA Received: 01/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1