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 08/10/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A facility employee complained of burning eyes, nose and throat after working with the dsd edge aer and rapicide pa.The next day they had tightness of chest and labored breathing.The employee was sent to the emergency room by supervisor and was checked out the next day.They were treated for the breathing problems and have had no issues since.Medivators ra followed up with this facility via phone call.It was confirmed that the handler, who had experienced these symptoms, has since been removed from the reprocessing area and is doing fine.It was repeatedly reported by the facility that the exposure symptoms were unlikely caused by the medivators dsd edge or rapicide pa.This facility uses cidex opa to manually reprocess scopes which could also potentially be the cause of the exposure symptoms.After the incident, this facility reported that they installed a charcoal filtration system for better room ventilation and they purchased special goggles for better eye protection.Medivators fse was dispatched to evaluate the machine and confirmed that the device is operating according to specification.There are no other reports of serious injury or illness as a result of exposure symptoms at this facility.This complaint will continue to be maintained within medivators complaint system.

Event Description

A facility employee complained of burning eyes, nose and throat after working with the medivators dsd edge automated endoscope reprocessor.These symptoms are potentially related to rapicide pa high level disinfectant exposure.

• Brand Name: RAPICIDE PA
• 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 5061247
• MDR Text Key: 25171038
• Report Number: 2150060-2015-00026
• Device Sequence Number: 1
• Product Code: FEB
• 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: Other
• Remedial Action: Patient Monitoring
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DSD EDGE AER
• Patient Outcome(s): Hospitalization