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

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fever (1858)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® nx 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 two patients.There was no report of infection, injury or harm to the first patient associated with this issue.However, patient #2 reported to have a fever before the operation was performed and still had a fever post-operatively.No additional information is available regarding the patient.Based on the new information received, there is no potential serious injury reported that was related to an asp product.The patient had symptoms before the operation was performed and before the instruments were even used.However, advanced sterilization products (asp) has determined in this situation sterility cannot be assured and, as a matter of policy asp had decided to report all incidents of positive cyclesure® 24 biological indicators when the loads have been released for use without reprocessing.

Manufacturer Narrative

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 for the previous six months 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 and further analysis.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause could not be verified.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification, 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.An issue with sterrad performance is also unlikely as the unit was serviced and no problem was found.A customer letter was sent regarding the user error of releasing the load for use without reprocessing first.The issue will continue to be tracked and trended.(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: 8051737
• MDR Text Key: 126658007
• Report Number: 2084725-2018-00754
• 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: 10/17/2018

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: 01/31/2019
• Device Catalogue Number: 14324
• Device Lot Number: 03218015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD® 100S (B)(4)