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 12/22/2014 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.Eleven bis were returned.Ten unsued bis were received for functional evaluation.One suspect positive bi was received with a gold chemical indicator (ci) disc, no media present but spore disc stained yellow.No manufacturing anomalies were observed in the suspect positive bi.Ten bis were submitted for functional evaluation.Two bis were used as controls.All eight 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.
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