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

Catalog Number 14324

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

Catalog number - the correct catalog number is 14324_97.Lot number - the correct lot number is 16816090.Expiration date - the correct expiration date is 05/31/2017.

Event Description

A customer reported that there was no growth in the cyclesure® 24 biological indicator (bi) positive control after 24 hours of incubation.It was later discovered that the incubator was at 70 degrees celsius and the bi's were unable to incubate properly.The instructions for use states for the biological incubator should be set to 55-60 degrees celsius and to read the results after 24 but prior to 72 hours of incubation.The customer stated no load was affected however, it is not known how long the incubator had not been working correctly as the customer stated the incubator was not able to calibrate to a lower temperature.Advanced sterilization products (asp) has decided to report this as an over abundance of caution since it is unknown how long the incubator had been not working properly.Asp will continue to follow-up for further information.

Manufacturer Narrative

The correct concomitant device information is sterrad incubator 120v: catalog# 21005, serial number# (b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), trending of the product malfunction code, trending of lot number, system risk analysis (sra), and product return 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 06/16/2016 to 09/26/2016 and trending was not exceeded.¿ the sra indicates the risk associated with exposure toa quality problem with no impact on safety is "low." ¿ retains testing and a visual analysis was not performed as the issue was due to user error.A temperature issue was found with the performance of concomitant product incubator.The incubator was put into service in 2004 and was beyond the one year warranty.The performance issue is attributed to normal wear and tear.The customer purchased a new incubator and the complaint issue was resolved.The assignable cause was found to be user error.The user incubated the positive bi control at 70 degrees celsius which is outside of the specified temperature range.Additionally, 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.A customer letter will be sent to educate the customer about the correct incubation temperature range for the bi's.The issue will continue to be tracked and trended.

• Brand Name: STERRAD® CYCLESURE® 24 BIOLOGICAL 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: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6056025
• MDR Text Key: 58359822
• Report Number: 2084725-2016-00649
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14324
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1