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

Model Number DSD-201

Device Problem Programming Issue (3014)

Patient Problem No Code Available (3191)

Event Date 03/17/2015

Event Type  No Answer Provided  

Event Description

A medivators field service engineer (fse) observed that the facility's dsd-201 automated endoscope reprocessors (aer) were running the incorrect program while using rapicide opa/28 high-level disinfectant.The program setting had the incorrect temperature for the opa disinfectant.The fse showed the facility the instructions for use for rapicide opa/28, which states the temperature it should be used at.Not using the disinfectant at the correct temperature could result in endoscopes not being properly disinfected, which could lead to cross-contamination.

Manufacturer Narrative

A medivators field service engineer (fse) observed that the facility's dsd-201 automated endoscope reprocessors (aer) were running the incorrect program while using rapicide opa/28 high-level disinfectant.The program was set to the incorrect temperature for the opa disinfectant.The opa temperature was 17c.The fse showed the facility the instructions for use for rapicide opa/28, which states the temperature it should be used at as 25c.Not using the disinfectant at the correct temperature could result in endoscopes not being properly disinfected, which could lead to cross-contamination.The facility checked several scopes and all were contaminated.There is limited information to the total number of patient procedures performed with improperly disinfected scopes.Medivators has not been notified of any patient illness or injury as a result of this incident.This complaint will continue to be monitored in the medivators complaint handling system.

• Brand Name: MEDIVATORS 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: 4646583
• MDR Text Key: 5681161
• Report Number: 2150060-2015-00007
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/27/2015

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: Medical Assistant
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2005
• 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
• Treatment: RAPICIDE OPA/28