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

Model Number ML02-0117

Device Problem Use of Device Problem (1670)

Patient Problems Skin Irritation (2076); Chemical Exposure (2570)

Event Date 12/09/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A nurse showed signs of skin chemical exposure symptoms after handling an endoscope that had been reprocessed in a medivators dsd edge automated endoscope reprocessor (aer) with rapicide pa high-level disinfectant.The nurse washed her hands and the exposure symptoms went away after 15 minutes.No additional medical treatment was sought.Medivators field service engineer (fse) went to the site to check the aer's water flow to ensure it was adequately rinsing endoscopes during reprocessing cycles.The aer operated according to specification and no issues were found.While at the site, the fse observed the reprocessing operator not changing gloves at the appropriate times and instructed her on proper procedures on when to change gloves after replacing rapicide pa bottles.If gloves are not changed at appropriate times, there is potential that pa residual on gloves could be transferred to items such as endoscopes, therefore potential for chemical exposure.To date, there have been no further known skin exposure complaints at this facility.This complaint will continue to be monitored by the medivators complaint handling system.

Event Description

A nurse showed signs of skin chemical exposure symptoms after handling an endoscope that had been reprocessed in a medivators dsd edge automated endoscope reprocessor (aer) with rapicide pa high-level disinfectant.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Type of Device: HIGH-LEVEL DISINFECTANT
• 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: 5343476
• MDR Text Key: 35033666
• Report Number: 2150060-2015-00044
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/05/2015

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
• Device Operator: No Information
• Device Model Number: ML02-0117
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DSD EDGE AER