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

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/16/2014

Event Type  malfunction  

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 10 hours.After sterilization the chemical indicator (ci) changed color correctly.The load included 1 olympus rigid scope, 1 olympus camera head, 1 light source code, 10 laparo forceps and 1 edge of electrode knife.The load was partially released and used on patient(s) before the results were confirmed.The load items released were the 1 olympus rigid scope, 1 olympus camera head and 1 light source code.There was no injury or harm associated with the issue.This event is reported to the fda since the load was partially released and used on a patient(s) before the cyclesure® 24 biological indicator (bi) results were confirmed.

Manufacturer Narrative

Load not recalled and suspected positive bi.

Manufacturer Narrative

Device information: correction - expiration date: correcting from na to 03/31/2015.Manufacturer date: 09/24/2014.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of the product malfunction codes and lot number, failure mode and effects analysis (fmea), and health hazard evaluation (hhe).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 for the product code of 'suspected positive bi" was reviewed from december 2013 through november 2014 and revealed a significant trend which was addressed through capa.Trending analysis for the product code of ''load not recalled" was reviewed from december 2013 through november 2014 and no significant trend was observed.Trending analysis by lot number was reviewed from 09/24/2014 to 12/18/2014 and no significant trend was observed.The fmea was reviewed and indicates that the risk priority numbers (rpn) associated for the failure mode is at an acceptable level.The hhe was reviewed for the risk of using instruments from a load with a positive biological indicator (bi) result which leaves a potential risk of the load not being successfully sterilized, thus could potentially transfer pathogens to patients.Each sterilization cycle is also monitored with physical parameters and chemical indicators.For the general population, the body¿s defense mechanisms make the chance for any organisms to establish into the body and cause infection to be relatively rare, especially factoring in the frequent use of prophylactic antibiotics prior to surgery.If a patient were to become infected, medical intervention would be required to resolve the infection.It is unlikely for an infection to occur; however, should it occur it could be significant for patients at greater risk.The product malfunction code of "load not recalled" was added because the customer did not successfully recall all items in the load.It is not related to a functional failure of the product.Further investigation into this issue is not required since the code is used for medwatch reporting purposes.Twenty-two bis were returned.Twenty unsued bis were received for functional evaluation.One suspect positive bi was received with a gold chemical indicator (ci) disc and yellow media in the crushed vial.No manufacturing anomalies were observed in the suspect positive bi.One negative bi was received and had a gold ci disc with purple media in the crushed vial.Twenty bis were submitted for functional evaluation.Two bis were used as controls.All eighteen bis met specification with no damage or leakage observed after processing.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.Also, no damage or leakage was observed with the retains after processing.It is unlikely the suspected positive bi was caused by a performance issue as the retains and returned product met functional specification, dhr review found no anomalies that would contribute to a positive bi result, and lot history review found no significant trend in this lot.Also, no manufacturing anomalies were observed in the returned suspect bi that would contribute to a positive bi result.Sterrad® performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The cyclesure® retains met functional specification.As a result, there is not an issue with product performance when used per the instructions for use (ifu).A customer letter has been sent addressing the ¿load not recalled¿ issue.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
• MDR Report Key: 4370677
• MDR Text Key: 15127157
• Report Number: 2084725-2014-00400
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

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: 03/31/2015
• Device Catalogue Number: 14324
• Device Lot Number: 26714107
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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