MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE® BIO INDICATOR; INDICATOR, BIOLOGICAL

Model Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: sterrad 100s sterilizer, serial # unknown.(b)(4).

Event Description

A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100s cycle.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 load has been released and used on patient(s) prior to reprocessing.

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.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 six months prior to open date of complaint 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 returned for visual inspection.Therefore, the reported issue could not be confirmed.Retains testing was not completed as the lot has since expired.There is no evidence that the reported issue was related to the sterrad® 100s unit¿s performance as the subsequent bi was negative for growth.No further investigation into the concomitant asp product was completed as the customer declined to provide additional information.The assignable cause of the issue could not be confirmed.It is unlikely the suspected positive bi was caused by a manufacturing issue as the dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot.The customer stated subsequent bi was negative for growth.The customer declined to provide any additional information.Regarding the released load, an asp sales representative has since re-trained the customer to always follow the instructions for use which states: a positive result on a test bi signifies that a sterilization condition was not achieved.If a positive result is observed: follow the current hospital or healthcare facility¿s policies and procedures regarding quarantine, or retrieval, and reprocessing of potentially non-sterile instruments and notification of the physician(s).The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® BIO INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9215325
• MDR Text Key: 176076296
• Report Number: 2084725-2019-00967
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (y/n): N
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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: 01/31/2020
• Device Model Number: 14324
• Device Catalogue Number: 14324
• Device Lot Number: 08519014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1