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

Catalog Number	20390
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp has contacted the customer to offer retraining and to request for additional information; however, no further information was provided.Asp will continue to follow up for this event.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of cidex® opa solution being used at 17.2 degrees celsius to reprocess a transesophageal echocardiogram (teec) probe, and the probe was released and used on a patient.As per the cidex® opa instructions for use (ifu), the minimum temperature for reprocessing is 20 degrees celsius.There was no report of any injuries or human reactions.As a matter of policy since high level disinfection cannot be assured, advanced sterilization products (asp) has decided to report all incidents of cidex® opa solution being used under the minimum reprocessing temperature and the instrument was released and used on a patient.
Additional Manufacturer Narrative
The customer confirmed understanding of the instructions for use and declined product training for the staff who were involved with the reported issue.Asp investigation summary: batch review was not performed as the lot number for the cidex® opa solution was not available.Trending was not performed as the lot number for the cidex® opa solution was not available.Review of risk documentation shows the risk for exposure to biohazardous, pathogenic, or infectious material to be "low." supplier investigation and product evaluation was not performed as the lot number is not available, and the reported issue was determined to be user error.The most likely assignable cause is failure to follow the instructions for use, which requires cidex® opa solution to be at a minimum of 20 degrees celsius for manual processing, and utilization of a thermometer was recommended to ensure optimum conditions are met.Asp will continue to track and trend this issue.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 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 13046511
• Report Number: 2084725-2021-00455
• Device Sequence Number: 19280674
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K991487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown