A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 200 cycle.The bi was incubated for 40 hours.After sterilization the chemical indicator (ci) changed color correctly.The nine subsequent bi results were negative.The load included two park med doppler probes, two stryker cameras (model 1198), and one da vinci robotic telescope.The load was partially released and used on patients before the results were confirmed.It is unknown which specific items were released.There was no injury or harm associated with the issue.This event is reported to the fda since the load was released and used on a patient(s) before the cyclesure® 24 biological indicator (bi) results were confirmed.
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Manufacturer date: 08/21/2014.Asp investigation summary: the investigation included a review of the device history record, trending of the product malfunction codes and lot number, failure mode and effects analysis, and health hazard evaluation.¿ 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.The risk is categorized as "low." ¿ trending analysis for the product code of ''load not recalled" was reviewed from december 2013 through november 2014.The risk is categorized as "low." ¿ trending analysis by lot number was reviewed from 08/21/2014 to 12/09/2014.There were no similar incidents within this time frame.¿ the fmea was reviewed and indicates that the 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 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.Thirty-two (32) retains bis were subject to functional evaluation.All thirty-two bis met functional specification.Also, no damage or leakage was observed with the retains.The single cyclesure® 24 bi was returned for visual inspection.The chemical indicator disc was gold in color which indicates exposure to hydrogen peroxide.The crushed vial had yellow media confirming the positive result.No manufacturing related anomalies observed.It is unlikely the suspected positive bi was caused by a performance 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 no significant trend in this lot.Visual inspection revealed no manufacturing anomalies in the returned bi.Sterrad® performance is also unlikely as the cycle passed and subsequent bis were negative for growth.The severity of the suspected positive bi was defined as ¿limited.¿ tracking and trending data has not identified a trend that requires investigation.As a result, root cause evaluation will not be performed.The customer will be advised to follow the ifu for "load not recalled." the issue will continue to be tracked and trended.
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