MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE® 24 BIO INDICATOR; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).(b)(4).

Event Description

A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100s cycle.The bi was incubated for 24 hours.The chemical indicator (ci) changed color correctly.The previous and subsequent bi results were both negative.The affected load was released and used on a patient.There was no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of positive cyclesure® 24 biological indicators when the loads have been released prior to reprocessing.

Manufacturer Narrative

Upon further follow-up, the customer stated that the employee who processed the bi did not follow the instructions for use (ifu) and placed the bi on the electrode.Per the ifu, "place the sterrad cyclesure 24 bi in a tyvek® pouch and place the pouch in the most challenging area for the sterilant to reach.This is typically on the shelf close to the rear of the sterilizer." asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis, retains analysis and concomitant product evaluation.¿ the dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.¿ trending analysis by lot number was reviewed from november 2017 to may 2018 and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ the single cyclesure® 24 bi was not available for return and further evaluation.¿ retains testing was not performed since user error was determined to be the cause and the lot has since expired.¿ it is unlikely the there is an issue with the concomitant sterrad® 100s sterilizer since the cycle passed and the ci disc changed color correctly.Additionally, the previous and subsequent bi¿s were negative for growth.The assignable cause of the suspect positive bi is likely due to user error.The employee who processed the biological placed it on the electrode and was unaware not to place anything over the bi.The customer has since been retrained with the proper processing procedures and no further issues have occurred.The issue will continue to be tracked and trended.Product complaint # (b)(4).

• Brand Name: CYCLESURE® 24 BIO INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• 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: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7700285
• MDR Text Key: 114713470
• Report Number: 2084725-2018-00647
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 14324
• Device Lot Number: 23317256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1