MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX OPA SOLUTION; BIOCIDES SOLUTIONS

Catalog Number	20390
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported they do not monitor the temperature of their cidex® opa solution prior to use, and the cidex® opa solution was used for manual reprocessing on cpap instruments that were released and used on patients.There is no report of any patient injuries or infections.The instructions for use (ifu) states the solution must be at a minimum 68 degrees f for high level disinfection and should be measured prior to use.As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer does not follow the ifu when processing their instruments in cidex® opa solution since asp is not able to guarantee it has been high level disinfected.
Additional Manufacturer Narrative
An asp clinical education consultant advised the customer that efficacy cannot be assured if cidex® opa does not meet the minimum temperature specifications and reviewed with the customer the instructions for use.The customer also reported discontinuing use of cidex® opa.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
D4: lot #: correction from n/a to unk.H3: asp.Investigation summary: the investigation included a review of the batch history record, complaint trending by lot number, system risk analysis (sra) and supplier evaluation.The batch history record could not be reviewed as the lot number was not available.Complaint trending could not be performed as the lot number was not available.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the supplier was not notified as the issue was not identified as a manufacturing or functional issue.The likely assignable cause of this issue was due to user error as the cidex® opa solution temperature was not monitored prior to use according to the instructions for use.A customer letter will be sent regarding the minimum required temperature of the solution.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX OPA SOLUTION
• Common Device Name: BIOCIDES SOLUTIONS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10880807
• Report Number: 2084725-2020-50278
• Device Sequence Number: 11484229
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K991487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 20390
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 02/11/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/04/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1