MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS PASS THRU; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

A cantel field service engineer (fse) reported that the connection tubing of the chemistry dosing assembly in the facility's advantage plus pass-thru automated endoscope reprocessor (aer) was reversed causing high level disinfectant (hld) solution to be dispensed into the opposite basin during a reprocessing cycle.It was reported that the facility begun a reprocessing cycle of an endoscope in the right basin, however solution was dispensed into the other basin resulting in the endoscope not being high-level disinfected prior to use in a patient procedure.The facility reported noticing the issue several hours after four endoscopes were used in patient procedures, therefore there is risk of infection from potential patient cross-contamination.The facility has placed all affected endoscopes into quarantine and is performing analysis of contamination.Cantel fse repaired the aer by correcting the uptake tubing and performing test cycles to verify the hld solution was dispensed to the correct basin.To date, there have been no reports of adverse effects from the patients.All patients were examined the same day of their procedure and all were reported to be fine.Users are required to use test strips following a reprocessing cycle to test the minimum recommended concentration (mrc) of the high level disinfection solution.Test strips when used per instructions for use indicates mrc has been achieved.Intercept plus detergent was used in the reprocessing cycle of the aer and was properly dispensed therefore an adequate wash cycle was performed in the aer.While high-level disinfection may not have been achieved, test data shows that following proper manual cleaning processes as required of an endoscope prior to an automated reprocessing cycle will still achieve a significant reduction in soil and bioburden.The chemistry dosing lines and chemistry dosing assembly are clearly labeled indicating the corresponding chemistry basin.Fses are trained to ensure the correct tubing is attached to the correct connector as indicated by the labeling.Fses are also trained to confirm the aer is operating according to specification after service interventions by completing test cycles prior to returning the aer back to service.This is not a system malfunction.The advantage plus pass-thru is designed to monitor the status of the chemistry dosing assembly by measuring the amount of hld being dosed, and monitoring that the hld is sent from the chemistry dosing assembly to the basin.The reversed dosing lines is not considered an error condition as the system is not designed to monitor which basin the hld is delivered.It has been confirmed that this is not a systemic issue that occurs during the manufacturing process.Production work instructions are in place to verify the correct chemistry dosing tubing connections and that hld solution is delivered to the correct basin.If the tubing were reversed, it would be detected during final release testing of the aer.There have been no reported occurrences in the u.S.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

A cantel field service engineer (fse) reported that the connection tubing of the chemistry dosing assembly in the facility's advantage plus pass-thru automated endoscope reprocessor (aer) was reversed causing high level disinfectant (hld) solution to be dispensed into the opposite basin during a reprocessing cycle.It was reported that the facility begun a reprocessing cycle of an endoscope in the right basin, however solution was dispensed into the other basin resulting in the endoscope not being high-level disinfected prior to use in a patient procedure.The facility reported noticing the issue several hours after four endoscopes were used in patient procedures, therefore there is risk of infection from potential patient cross-contamination.The facility has placed all affected endoscopes into quarantine and is performing analysis of contamination.

• Brand Name: ADVANTAGE PLUS PASS THRU
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer Contact: lauren johnson ; 9800 59th ave n; plymouth, mn
• MDR Report Key: 9862858
• MDR Text Key: 196471303
• Report Number: 2150060-2020-00011
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• 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
• Patient Outcome(s): Other