MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Leak/Splash (1354); Inadequate or Insufficient Training (1643)

Patient Problem Chemical Exposure (2570)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported that two of their dsd edge automated endoscope re-processors (aer) were leaking rapicide pa.Facility personnel sought medical attention after exposure to the chemical.Medivators fse went onsite to evaluate the machines and observed that several dosing pumps and check valves were leaking.The fse reported that the facility's biomed was using 3rd party tubing and components to repair the aers.The tubing used was identified as the main source of the issue.During the aer evaluation, the tubing broke off and personnel were exposed to fully concentrated rapicide pa.Medivators ra followed up with the facility and learned the personnel in the reprocessing room were not wearing proper protective equipment at the time of the event.The medivators safety data sheet, instructions for use and label instructs the user to wear protective gloves/eye/face protection when operating the machine and handling rapicide pa.No exposure symptoms were reported but medical attention was sought.It was reported they are doing fine and back working.Medivators fse reported not experiencing any symptoms.The dsd edge user manual recommends customers regularly inspect the machine for basin, pipe, and tubing damage that could result in leaks.The user manual also recommends customers to order replacement parts from the manufacturer and that 3rd party parts have not been validated.Medivators fse have ordered new tubing and replaced it in both machines.The aers are operating in accordance to specification.On numerous occasions, medivators fse has recommended onsite training for facility staff, but have not received any follow up.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

A facility reported that two of their dsd edge automated endoscope re-processors (aer) were leaking rapicide pa.Facility personnel sought medical attention after exposure to the chemical.

• Brand Name: DSD EDGE
• 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: ann moua ; 14605 28th ave n; minneapolis, MN 55447 ; 7633182956
• MDR Report Key: 8757556
• MDR Text Key: 149926203
• Report Number: 2150060-2019-00051
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other