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

Model Number DSD-201

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 12/13/2013

Event Type  No Answer Provided  

Event Description

Facility reprocessing scopes at wrong "use settings" on the medivators dsd-201 machine using cidexplus 28 day solution.The settings were at 5 min contact/immersion @ 36 degrees celsius.Cidexplus dfu states that high level disinfection occurs when used at 25 degrees celsius with an immersion time of at least 20 minutes.

Manufacturer Narrative

Scopes at this facility were not adequately reprocessed using medivators dsd-201 aer for approximately 36 days.There is possibility of cross-contamination since the scopes reprocessed during this time frame were not high level disinfected properly due to incorrect programming required for use of cidexplus 28 day chemistry.The medivators dsd-201 aer settings per cycle during this 36 day time frame were: 5 min contact time @ 36 degrees celsius.Cidexplus 28 day reusable chemistry requires: at least a 20min contact time @ 25 degrees celsius.(reference attached photo1.Jpg - cidexplus 28 day disinfection requirements) according to (b)(4) center's administrator, (b)(4), there was approximately 80 procedures done during this time frame.She is actively trying to contact (b)(4) on efficacy studies of cidexplus 28day at these settings:5 min contact time @ 36 degrees celsius.Medivators fse (b)(4) reported his findings that the dsd-201 machine settings were inadequate for use with cidexplus 28 day while performing their annual pm.Upon this realization, he re-programmed the machine to accommodate the cidexplus chemistry requirements for high level disinfection.To date, there have been no reports of injuries or illness.This was confirmed on the conference call between medivators and (b)(4) center (b)(4) 2014.(b)(4) - conference call - follow up with (b)(4) and encouraged them to self-report the incident.They admitted that this was an honest mistake and have put the appropriate processes in place to prevent this issue for occuring in the future.This facility has switched to medivators rapicide gluteraldehyde hld.If additional information is received, medivators will review and determine if further action is required.

• Brand Name: MEDIVATORS DSD-201
• Type of Device: AUTOMATIC 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: 3551022
• MDR Text Key: 3983311
• Report Number: 2150060-2014-00001
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/30/2013

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: Other
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2013
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2011
• 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: CIDEXPLUS 28 DAY