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

Model Number ML02-0117

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Headache (1880); Chemical Exposure (2570)

Event Date 11/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A scope technician at the facility complained of chemical exposure symptoms of headache and respiratory problems while using rapicide pa high-level disinfectant with their dsd edge automated endoscope reprocessor (aer).The scope tech also reported on a separate occasion, rapicide pa went through her nitrile gloves and burned her skin.Medical treatment was sought for the respiratory problems.A medivators field service engineer (fse) went to the facility to check the dsd edge and found it to be operating in accordance to specifications.The fse found no spills or leaks and gave training on changing the disinfectant bottles.He watched cycles run and noted no excessive pa smell.The fse advised the facility to have the number of air exchanges per hour in the scope reprocessing room verified.Nitrile gloves are recommended for use with peracetic acid base solutions including rapicide pa.This complaint will continue to be monitored by the medivators complaint handling system.

Event Description

A scope technician at the facility complained of chemical exposure symptoms of headache and respiratory problems while using rapicide pa high-level disinfectant with their dsd edge automated endoscope reprocessor (aer).The scope tech also reported on a separate occasion, rapicide pa went through her nitrile gloves and burned her skin.

• 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: 5320075
• MDR Text Key: 34163776
• Report Number: 2150060-2015-00043
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/22/2015

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: Other
• Device Model Number: ML02-0117
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/22/2015
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: DSD EDGE AER