MAUDE Adverse Event Report: MEDIVATORS CER-1R; AUTOMATIC ENDOSCOPE REPROCESSOR

Model Number	CER-1
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Off-Label Use (1494)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a facility was reprocessing endoscopes with their cer-1 automatic endoscope reprocessor (aer) with the incorrect amount of rinses per the high-level disinfectant labeling and aer instructions-for-use.The facility was using cidex opa hld which requires 3 rinses but their aer was set up with 2 rinses.There is potential that endoscopes may have contained hld residual after reprocessing which could cause chemical colitis or adverse reactions to patients.Medivators discovered that the facility originally had their aer setup for using rapicide hld which requires 2 rinses.The facility switched to using cidex opa and did not have the firmware chip replaced in their aer to incorporate the 3rd rinse per the hld and aer instructions.Medivators informed the customer of the required 3 rinses for use with cidex opa and switched the firmware chip in their unit to have the correct amount of rinses.Cidex opa labeling and instructions and medivators cer-1 user manual clearly state 3 rinses are required when using cidex opa to reprocess endoscopes.It is unknown how long the facility had been using cidex opa with the incorrect amount of rinses.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
It was reported that a facility was reprocessing endoscopes with their cer-1 automatic endoscope reprocessor (aer) with the incorrect amount of rinses per the high-level disinfectant labeling and aer instructions-for-use.The facility was using cidex opa hld which requires 3 rinses but their aer was set up with 2 rinses.There is potential that endoscopes may have contained hld residual after reprocessing which could cause chemical colitis or adverse reactions to patients.

• Brand Name: CER-1R
• Common Device Name: AUTOMATIC ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7857564
• Report Number: 2150060-2018-00059
• Device Sequence Number: 11247908
• Product Code: NVE
• UDI-Device Identifier: 00677964021695
• UDI-Public: 00677964021695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K871712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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
• Operator of Device: Health Professional
• Device Model Number: CER-1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other