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

Model Number DSD-201LT

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/02/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that this facility had 2 dsd -201 automated endoscope reprocessors.The machines' programmed disinfectant cycle contact time and temperature settings were not inline with the instructions for use on metricide opa high level disinfectant (hld) being used.There is potential that high-level disinfection of the endoscopes was not achieved, thus potential patient cross contamination.Medivators field service team and sales representative are in close communication with this customer.It was reported that this facility has changed the programming on several occasions to shorten the cycle time.The facility was educated on the importance of cycle time/heating chemistry to achieve hld.There have been no reports of patient illness or injury.This complaint will continue to be monitored within the medivators complaint system.

Event Description

The case states that this facility had 2 dsd -201 automated endoscope reprocessors.The machines' programmed disinfectant cycle contact time and temperature settings were not inline with the instructions for metricide opa high level disinfectant being used.There is potential that high-level disinfection of the endoscopes was not achieved, thus potential patient cross contamination.

• 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 5117762
• MDR Text Key: 27250050
• Report Number: 2150060-2015-00028
• 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,health
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Report Date: 10/01/2015

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-201LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2002
• 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