MAUDE Adverse Event Report: MEDIVATORS CER-2; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number CLMAC-MV2R

Device Problem Temperature Problem (3022)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/23/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A medivators clinical specialist went to the facility to check on their medivators cer automated endoscope reprocessor (aer) disinfectant reservoir that was not heating properly.The facility was using rapicide high level disinfectant which has a use temperature of 35 degrees celsius.The reservoir temperature was displaying 21 degrees celsius.The clinical specialist informed the facility to either replace or repair the reservoir or switch to manual disinfection using opa.Reprocessing endoscopes at the incorrect temperature could result in scopes not being properly disinfected, therefore potential for patient cross-contamination.The clinical specialist followed up with the facility via email on (b)(6) 2015 and they had a new heated reservoir installed.To date, there have been no complaints of patient cross-contamination.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

A medivators clinical specialist went to the facility to check on their medivators cer automated endoscope reprocessor (aer) disinfectant reservoir that was not heating properly.The facility was using rapicide high level disinfectant which has a use temperature of 35 degrees celsius.The reservoir temperature was displaying 21 degrees celsius.The clinical specialist informed the facility to either replace or repair the reservoir or switch to manual disinfection using opa.Reprocessing endoscopes at the incorrect temperature could result in scopes not being properly disinfected, therefore potential for patient cross-contamination.

• Brand Name: CER-2
• 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: 5159774
• MDR Text Key: 28667327
• Report Number: 2150060-2015-00032
• Device Sequence Number: 1
• Product Code: NVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871712
• 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: Replace
• Type of Report: Initial
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CLMAC-MV2R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2006
• 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 HIGH LEVEL DISINFECTANT AND STERILANT