Date of event: unknown.Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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H6: investigation summary scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: fluid leak manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 20oct2020 to date 20oct2021 (rolling 12 months).Complaint trend: there are 11 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 20oct2020 to date 20oct2021 (rolling 12 months).Investigation result / analysis: per fse report: liquid is leaking on the line from the wash station.The connector for the inline filter connection was damaged.Replaced damaged coupling.Leakage has been improved by replacing the coupling.After replacement, checked the initialization operation and confirmed that there is no liquid leakage.Service max review: review of related work order# (b)(6), install date: (b)(6) 2016 defective part number: 640521 coupling insert valve work order notes: subject / reported: fluid leak, problem description: fluidic leak, cause: damaged connector, work performed: replaced damaged connector/coupling, solution: replaced damaged connector/coupling.Returned sample evaluation: did not request return of defective parts manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 02 was reviewed.Hazard(s) identified? yes, no.Hazard id: 3.1.29.Hazard: environmental biohazard.Severity: 5.Probability: 1.Risk index: 5.Implementation: bd facs sample prep user¿s guide.Risk control:_alarp.Mitigation(s) sufficient yes, no.Root cause: based on the investigation result and the fse¿s report the root cause was a damaged coupling.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the fluid leak h3 other text : see h10.
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