MAUDE Adverse Event Report: MEDIVATORS CER OPTIMA 2; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported filters were replaced and high level disinfectant was in the housings to perform water line disinfect.Filter housings were under pressure so when unscrewed caused fluid to be sprayed.The high level disinfectant used is unknown.There was exposure to 2 employees' faces.The affected people were wearing ppe.It was reported they sought medical attention.It was reported the filters were reseated properly and system is now operational.This complaint could potentially be a serious injury.There has been no update on condition of exposed personnel.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility was performing regular maintenance in changing the filters which require water line disinfection.At some point during this process they unscrewed the filter housing while under pressure.Disinfectant eye exposure symptoms reported.

• Brand Name: CER OPTIMA 2
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 6354158
• MDR Text Key: 68168225
• Report Number: 2150060-2017-00009
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K87172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• 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