MAUDE Adverse Event Report: MEDIVATORS CER OPTIMA AER; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number LCLMAC-MV2R

Device Problem Fumes or Vapors (2529)

Patient Problem Chemical Exposure (2570)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

Medivators sales representative reported three facility employees were experiencing possible health problems from exposure to rapicide high-level disinfectant (hld) fumes when reprocessing endoscopes in their cer-2 optima automatic endoscope reprocessing (aer) units.There is potential for chemical exposure symptoms from rapicide hld fumes.Medivators regulatory contacted the facility and they reported that they were routinely reprocessing endoscopes and noticed irritation from the hld.The facility confirmed that they were wearing the required ppe including a gown, mask and gloves.The facility reported that no medical attention was sought.They have discontinued use of the aers and they are being returned to medivators for further evaluation.Medivators clinical educator confirmed they did not notice any excessive fumes or odors while on site installing the aers.They reported discussing the ventilation requirements with the facility and recommended the facility should check the air exchanges in the room and that a hood was available if needed.The clinical educator also confirmed the aers were operating according to specification.As stated in the cer optima aer site requirements document, it is a health and safety requirement for facilities to have a minimum of 10 air changes per hour in the reprocessing room to minimize staff exposure to chemical vapors.The rapicide labeling and sds also instruct users to avoid breathing fumes and to wear ppe when handling.This complaint will continue being monitored in medivators complaint handling system.

Event Description

Medivators sales representative reported three facility employees were experiencing possible health problems from exposure to rapicide high-level disinfectant (hld) fumes when reprocessing endoscopes in their cer-2 optima automatic endoscope reprocessing (aer) units.There is potential for chemical exposure symptoms from rapicide hld fumes.

• Brand Name: CER OPTIMA AER
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS,INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: laurie weir ; 14605 28th ave n; minneapolis, MN 55447 ; 7638984328
• MDR Report Key: 9444502
• MDR Text Key: 170705447
• Report Number: 2150060-2019-00061
• Device Sequence Number: 1
• Product Code: NVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LCLMAC-MV2R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other