H6: investigation summary scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146 and serial # (b)(6).Problem statement: customer reported complaint on the instrument's waste tank is leaking at the base manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 02feb2020 to 02feb2021.Complaint trend: there are 5 complaints related to the issue of the instrument's waste tank leaking at the base; date range from 02feb2020 to 02feb2021.Manufacturing device history record (dhr) review: dhr part # 337146 serial # (b)(6) , file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the waste leakage not contained within the instrument was due to a worn waste tank.The customer called regarding a leaking waste tank (pn 33634907) and requested for one to be sent to them.When the part arrived onsite the customer was able to install the tank onto their instrument without an fse¿s assistance.No parts were requested for evaluation as the waste tank is not a returnable part and was discarded.After the repair the customer confirmed that the instrument was tested and performing as expected.Although the leakage of biohazard has the potential for injury and contamination, no customer or bd personnel came in direct contact and was thus not harmed due to the issue.The leakage was not under pressure and did not significantly increase the risk of exposure.The customer confirmed that though patient samples were used, they were not used in any treatment due to the leakage and didn¿t harm the patient in any way.The safety risk is severe, s4, though there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: 30jun2006.Defective part number: n/a.Work order notes: subject / reported: 337146 - bd facs lyse wash assistant - waste tank leakage.Problem description: the instrument's waste tank is leaking at the base.Work performed: confirmed by ashleigh curtis that new waste tank can be sent.Sent tank 33634907.Cause: broken waste tank assembly.Solution: the customer confirmed the new tank arrived, and that installing it resolved the issue.Returned sample evaluation: a return sample was not requested because the replaced part is not returnable and was discarded.Risk analysis: risk management file part # 337146 fmea, rev.03/vers.C, lyse wash assistant fmea disinfectant project was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? ¿yes ¿no.Id: 20.1.Item: bd disinfectant.Function: contain the waste.Potential failure mode: integrity of waste tank compromised.Potential causes: incompatibility of antifoam with pp waste tank material.Local and next-level effects: waste leaks out of the tank.Hazards: chemical/biohazard due to incompatible material/chemical reaction.Risk controls: disinfectant added to waste tank; samples lysed and/or fixed; anti-foam msds.Effectiveness verification: refer to memo: steris vesta syde sq product chemical compatibility with anti-foam and waste tank.Probability: 1.Severity: 4.Risk index: 4.Output: none.Mitigation(s) sufficient ¿yes ¿no.Root cause: based on the investigation results the root cause of the leakage not contained within the instrument was due to a worn waste tank.Conclusion: based on the investigation results, the root cause of the leakage of waste not contained within the instrument was due to a worn waste tank.The customer called regarding the leakage due to a worn waste tank and requested for one to be sent to them.Upon arrival of the part, the customer successfully installed the waste tank onto the instrument.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is moderate, s3, and there was no impact to patient health or safety.H3 other text : see h10.
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