MAUDE Adverse Event Report: MEDIVATORS RAPICIDE HIGH-LEVEL DISINFECTANT AND STERILANT

Model Number ML02-0059

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problems Headache (1880); Chest Tightness/Pressure (2463); Chemical Exposure (2570)

Event Date 12/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

It was reported that the operator complained of chemical exposure symptoms of headache and heavy chest after changing out rapicide high-level disinfectant and sterilant in their ssd-102 automated endoscope reprocessor (aer).A disinfectant dump of the aer was in progress when the operator began to change out the rapicide.The vapor management exhaust hose was accidently bumped and the hose disconnected.While the hose was disconnected, the operator was exposed to rapicide fumes that would have normally been evacuated through the exhaust hose.Medical treatment was sought for the exposure symptoms.Medivators environmental health and safety spoke with the operator and explained both routine ppe and spill response ppe for use with rapicide.This complaint will continue to be monitored by the medivators complaint handling system.

Event Description

It was reported that the operator complained of chemical exposure symptoms of headache and heavy chest after changing out rapicide high-level disinfectant and sterilant in their ssd-102 automated endoscope reprocessor (aer).

• Brand Name: RAPICIDE HIGH-LEVEL DISINFECTANT AND STERILANT
• 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: 5369435
• MDR Text Key: 36043221
• Report Number: 2150060-2016-00002
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0059
• Date Manufacturer Received: 12/17/2015
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: MEDIVATORS SSD-102