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

Catalog Number 20391

Device Problems Failure to Disinfect (1175); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 05/19/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone #: (b)(6).(b)(4).Test specifications for product release were met.No issues were observed that would contribute to the complaint.(b)(4).

Event Description

It was reported from a customer there are four patients with infections or ¿urological sepsis¿ after having ureteroscopy procedures with instruments processed in cidex® opa solution.During follow-up for additional information, advanced sterilization products (asp) became aware that the customer was not testing their cidex® opa solution for the minimum effective concentration (mec) prior to use and did not monitor the temperature of the solution prior to use.The instructions for use (ifu) states the concentration of this product during its reuse life must be verified by the cidex® opa solution test strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the mec of 0.3%.The product must be discarded after 14 days, even if the cidex® opa solution test strip indicates a concentration above the mec.The ifu also states ¿during the usage of cidex® opa solution as a high-level disinfectant, it is recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met.¿ the customer stated their re-use solution was used for four days and that the instruments were immersed and high-level disinfected in the cidex® opa solution for five minutes which is in accordance with the ifu.This file is for patient # 4.No further information regarding the patient¿s symptoms is known at this time after multiple attempts.Asp will continue to follow-up for information.Based on very limited information received and out of an abundance of caution, this complaint is reportable as a serious injury for infection.It should be noted patient 4 symptoms and severity are unknown.It is also unknown if patient 4 had pre-existing symptoms of infection prior to the procedure using instruments reprocessed in cidex® opa solution.There is no confirmed infection related to the direct use of cidex® opa solution, and there is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure.Upon follow-up, it was identified the customer made multiple user errors, and did not follow the ifu: they did not monitor the temperature to determine appropriate temperature is met and they did not use cidex® opa test strips to test the mec of cidex® opa solution, and loads were released and used on patients; therefore, it is determined high level disinfection cannot be assured, and asp has decided to report this incident as a matter of policy.Asp has requested additional information regarding this event, and this complaint will be reassessed if new information becomes available.(b)(4) are related complaints from the same facility.This is four of four 3500a reports being submitted for this event.Please reference manufacturer report numbers: 2084725-2019-00891, 2084725-2019-00888, and 2084725-2019-00889.

Manufacturer Narrative

The unused portion of the cidex opa solution remaining in the container was returned and tested and the unused solution met all product specifications.Retains testing for this lot was performed by the supplier and all test specifications were met.Upon follow-up, the customer states no further information is available regarding the patient.Asp complaint ref #: (b)(4).

Manufacturer Narrative

It was reported this patient was diagnosed with infection, not sepsis as previously reported.It was reported that this patient has since recovered.It was noted that the same instrument was used on all four patients and was cleaned and reprocessed in between procedures.Regarding the cidex opa solution, it was reported the solution was opened for one week prior to the facility reporting these events.The solution was stored in a cabinet with other disinfectants and chemicals and the solution was poured into containers that did not have tight fitting lids.H6: patient codes - 3191 - no code available "urosepsis" was reported in the initial report and should be removed.Asp complaint ref #: (b)(4).

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record, complaint trending by lot number, system risk analysis (sra), visual analysis, supplier product evaluation and retains analysis.Complaint trending by lot number was reviewed from the prior six months to open date and no significant trend was observed.The sra shows the risk for exposure to biohazardous, pathogenic, or infectious material to be low.The returned sample was tested by the supplier and confirmed the product met all specifications except for appearance.The reason for the transparency in color could not be identified since the customer did not confirm if the cidex opa solution was observed as colorless and odorless before use when the bottle was initially opened or during use and no further information can be obtained.The assignable cause of this issue of not monitoring the cidex opa solution for the mec prior to use and not monitoring the temperature of the solution prior to use is due to user error and not following the instructions for use (ifu).Customer re-training was provided to the facility on proper use.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: EMEA CIDEX® OPA SOLUTION
• Type of Device: BIOCIDES SOLUTIONS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8719557
• MDR Text Key: 148798281
• Report Number: 2084725-2019-00890
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• PMA/PMN Number: K991487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 20391
• Device Lot Number: 250618170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/29/2019; 08/02/2019; 09/16/2019
• Supplement Dates FDA Received: 07/24/2019; 08/22/2019; 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1