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

Model Number	ML02-0059
Medical Device Problem Codes	Leak/Splash (1354); Inadequate or Insufficient Training (1643)
Health Effect - Clinical Codes	Dizziness (2194); Sore Throat (2396); Chemical Exposure (2570)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported that four facility personnel were exposed to medivators rapicide high level disinfectant (hld) when an operator inadvertently spilled the hld while filling the reservoir in their dsd-201 automated endoscope reprocessor (aer).It was reported that one of the personnel experienced dizziness, throat irritation and a cough.Medivators ra followed up with the facility and it was reported that a technician did not turn off the machine while refilling one of the reservoirs, causing about a gallon of rapicide hld to spill on the floor.The facility reported that the personnel exposed to rapicide hld were not wearing any personal protective equipment (ppe) at the time of the spill and they did not put on ppe until cleaning up the spill.The facility reported that one operator experienced exposure symptoms including dizziness, throat irritation and a cough.They were sent to the er for additional medical attention.The facility reported that the individual's exposure symptoms went away after getting some fresh air.Other facility personnel were not reported to have experienced any exposure symptoms.The dsd-201 user manual, rapicide hld ifu and safety data sheet (sds) instruct users to wear protective gloves/eye/face protection while handling rapicide hld.The dsd-201 user manual also specifies that the disinfectant reservoir capacity is 15 liters.Anything more than 15 liters will cause an overflow.The facility takes full responsibility of the incident, citing off label use and lack of training.The facility reported that they are updating their processes and are open to onsite training.Medivators ra provided the facility with the rapicide hld sds and contact information to schedule additional onsite training.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
A facility reported that four facility personnel were exposed to medivators rapicide high level disinfectant (hld) when an operator inadvertently spilled the hld while filling the reservoir in their dsd-201 automated endoscope reprocessor (aer).It was reported that one of the personnel experienced dizziness, throat irritation and a cough.

• Brand Name: RAPICIDE DISINFECTANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8821650
• Report Number: 2150060-2019-00054
• Device Sequence Number: 3258355
• Product Code: MED
• UDI-Device Identifier: 00677964034855
• UDI-Public: 00677964034855
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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
• Operator of Device: Other
• Device Model Number: ML02-0059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR
• Outcome Attributed to Adverse Event: Other