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

Model Number ML02-0117

Device Problem Fumes or Vapors (2529)

Patient Problem Chemical Exposure (2570)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a strong rapicide pa high level disinfectant (hld) fumes emanating from the room of their advantage plus automated endoscope reprocessor (aer) causing three facility staff to experience exposure symptoms.Medivators received new information on december 11th reporting that three employees experienced burning eyes and throat from the hld fumes in the room of their aer.Medivators field service engineer (fse) was on site to investigate the facilities aer.The medivators fse reported when they arrived on site they could not detect a smell.The fse reported the facility is following the recommended air exchanges per hour and both aers in the room were tested and ran within specification.The facility reported they repaired their exhaust fan in their aer room which helped to reduce the hld fumes.They confirmed no employees sought medical attention for their exposure symptoms and all are reported to be doing fine.This will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported a strong rapicide pa high level disinfectant (hld) fumes emanating from the room of their advantage plus automated endoscope reprocessor (aer) causing three facility staff to experience exposure symptoms.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 8151799
• MDR Text Key: 129948210
• Report Number: 2150060-2018-00074
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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