MAUDE Adverse Event Report: MEDIVATORS RAPICIDE; HIGH-LEVEL DISINFECTANT

Model Number	ML02-0059
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators clinical education specialist reported after the facility reprocessed endoscopes in their automated endoscope reprocessor with rapicide glutaraldehyde chemistry, they used rapicide opa test strips to check the minimum required concentration (mrc) of the high-level disinfectant.In accordance with the instructions for use, rapicide test strips should be used to test the mrc of the chemistry.There is potential the reprocessing cycles did not reach high-level disinfection.The rapicide opa test strips and rapicide glutaraldehyde test strips are formulated differently, thus the opa test strips could indicate a passing mrc when the rapicide glutaraldehyde is actually below the mrc.The facility had been using the incorrect test strips for approximately 1 month.Medivators clinical education specialist instructed the facility to stop using the opa test strips and to stop reprocessing endoscopes until they have the appropriate test strips to perform the mrc test.She remains in close contact with the director and nurse manager at the facility.The facility has since ordered the correct test strips.There has been no report of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators clinical education specialist reported after the facility reprocessed endoscopes in their automated endoscope reprocessor with rapicide glutaraldehyde chemistry, they used rapicide opa test strips to check the minimum required concentration of the high-level disinfectant.In accordance with the ifu, rapicide test strips should be used to test the mrc of the chemistry.There is potential the reprocessing cycles did not reach high-level disinfection.

• Brand Name: RAPICIDE
• Common Device Name: HIGH-LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7643910
• Report Number: 2150060-2018-00045
• Device Sequence Number: 16619258
• Product Code: MED
• UDI-Device Identifier: 00677964034855
• UDI-Public: 00677964034855
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K993042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: No Information
• Device Model Number: ML02-0059
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/27/2018
• 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