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

Model Number ML02-0117

Device Problems Fumes or Vapors (2529); Ventilation Problem in Device Environment (3027)

Patient Problems Abdominal Pain (1685); Chest Tightness/Pressure (2463); Chemical Exposure (2570)

Event Date 10/20/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The (b)(4) field service engineer (fse) was visiting a customer for preventive maintenance (pm).The fse spent 7 hours working on 2 (b)(4) reprocessing machines, which included draining and replacing rapicide glutaraldehyde.It was reported that there was minimal ventilation in the room and the ventilation system didn't seem to be working.It should be noted that two days prior he performed a pm at a different location with approximately 3 hours of exposure to the same product.The fse began experiencing chest pain, tightness in his throat, difficulty breathing, low back pain and sharp pains in his stomach.The fse went to er where they performed diagnostics.Follow up medical attention was sought.Current status of affected persons unknown.(b)(4) has informed the facility of the reprocessing room ventilation issues and made them aware of the potential exposure effects.This complaint will continue to be monitored in (b)(4) complaint handling system.

Event Description

The case states that (b)(4) field service engineer experienced chemical exposure symptoms while performing preventative maintenance on a dsd-201 automated endoscope reprocessor.The reported symptoms include chest pain, tightness of the throat, difficulty breathing and sharp pains to the stomach.

• Brand Name: RAPICIDE GLUTARALDEHYDE
• 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: 6115022
• MDR Text Key: 60414610
• Report Number: 2150060-2016-00046
• Device Sequence Number: 1
• Product Code: MED
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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: DSD-201 AER
• Patient Outcome(s): Hospitalization