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

Catalog Number 14324

Device Problems Chemical Problem (2893); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® sealsure chemical indicator tape.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14202.

Event Description

A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.The affected load was reprocessed.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 sterrad® sealsure chemical indicator tape not changing color correctly.One-10w3k9a and 1-10w3m45 are related complaints from the same facility.This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2017-00232 and 2084725-2017-00233.

Manufacturer Narrative

Lot # correction from 241916 to unknown.Exp date: correction from 7/5/2018 to unknown.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis by lot number, retains analysis, system risk analysis (sra), visual analysis and concomitant product evaluation.¿ the dhr review, complaint trending by lot number and retains testing were not performed as the lot number provided was an invalid lot number and multiple attempts at follow-up with the customer were unsuccessful.¿ the sra indicates the risk associated with a quality problem with no impact on safety is "low." ¿ the product was not returned; therefore, no visual analysis was performed.¿ the concomitant sterrad 100s was evaluated and tested by an asp field service engineer (fse).The issue was resolved by calibrating the baratron(s) and cleaning the door assembly.The completed the corrective maintenance and the unit met specifications after the service.The likely assignable cause of the issue can be attributed the concomitant sterrad 100s.The fse completed the corrective maintenance on the unit and the issue was resolved.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: 6565317
• MDR Text Key: 75102178
• Report Number: 2084725-2017-00233
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2018
• Device Catalogue Number: 14324
• Device Lot Number: 241916
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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