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Medical device expiration date: na.The event described occurred on an ce-ivd instrument, but it is considered to be substantially similar to the legally u.S.Marketed ivd version of the instrument.The ivd instrument¿s 510k has been reported.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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It was reported that while running patient samples on bd facslyric¿ 3l10c instrument carryover occurred.There was no patient impact.The following information was provided by the initial reporter, translated from portugues to english: last wednesday ((b)(6) 2022) the equipment was performing properly and after monthly cleaning the equipment was clogged.The probe kept dripping, sit flush and clean cuvette not working, as has been the case for the last few months.Dr informed the team that the equipment had carryover and we were notified to start the investigation of the case.
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H6: investigation summary: scope of issue: the scope of issue is only limited to facslyric 3l10c instrument, part # 659180, serial # (b)(6).Problem statement: customer reported a complaint regarding the instrument producing high carry over.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 25mar2021 to date 25mar2022.Complaint trend: there are 16 complaints related to the issue of high carry over.Date range from 25mar2021 to date 25mar2022.Manufacturing device history record (dhr) review: dhr part #659180 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 carryover was due to a dirty flowcell.The customer had reported that their instrument was having issues clogging after every monthly clean.The facslyric calibration report exhibited a failure in the high sensitivity mode.An fse (field service engineer) was sent onsite to observe the issue and they performed a technical analysis to find the cause.The fse found a failure with the flowcell ((b)(4)) and replaced it along with the sitflush hose.They then aligned the lasers and made adjustments to the system.After the repair, the instrument was tested with cqc and pqcs and confirmed to be functioning as expected.The sit flush hose was not requested for evaluation as it is not returnable and was discarded.The flowcell was not requested for return and evaluation as the fse provided a description of the issue in the attached email ¿re flowcell failure details ¿(b)(4)¿.Although the unexpected results were from patient samples for clinical use, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnosis decision and was reported to bd as not expected.There was no delay in patient treatment due to any unexpected results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facslyric¿ clinical system instructions for use, #23-19938-02 rev.1/vers.A.The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: (b)(4), case # (b)(4) install date: 18mar2019.Defective part number: 65048807 - flow cell service.Work order notes: subject / reported: carryover.Problem description: customer returned in contact reporting that they are having a constant problem with lyric: the equipment flush site has been clogged every time the monthly clean is performed.This issue was noted again today and added to the fact that dr maura evidenced carryover in patient samples.We are waiting for the client's email with the files to evaluate the case and prepare the action plan.Work performed: after technical analysis, a failure was found in the flow cell, the exchange of the flow cell and the sitflush hose was carried out, the alignment of the lasers and adjustments to the system were carried out.After the adjustments, the cqc and pqc were performed and all parameters passed perfectly.Equipment tested and released for use.Doc.N10000244629 rev 06 version f.Cause: flow cell failure.Solution: after technical analysis, a failure was found in the flow cell, the exchange of the flow cell and the sitflush hose was carried out, the alignment of the lasers and adjustments to the system were carried out.After the adjustments, the cqc and pqc were performed and all parameters passed perfectly.Equipment tested and released for use.Doc.N10000244629 rev 06 version f.Returned sample evaluation: a return sample was not requested because although the part (65048807 - flow cell service) was replaced, the cause of failure had already been evaluated.Upon contact with the fse that worked on this instrument, they reported that excessive light on the cuvette caused reflections in the results, and this was caused by dirt on the walls of the flowcell.Risk analysis: risk management file part # (b)(4), rev.07/vers.Aa, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes/ no? azure id: (b)(4).Id: libivd-ra-94 3.1.4.Reg status: ivd; ruo.Hazard: incorrect output.Cause: dirty flow cell.Harmful effects: poor separation and gates do not work as desired leading to wrong result.Risk control: daily qc shall capture the need to clean flow cell.Monthly fluidic clean and clean flow cell modes shall clean the flow cell.Req link (azure id): (b)(4) libivd-fld-274 cuvette cleanliness, 93105 libivd-did-508 instrument qc.Implementation verification: libivd-se-15-84ar, cuvette cleanliness protocol lsv1004-dp.Effectiveness verification: libivd-se-15-84ar, cuvette cleanliness protocol report lsv1004-dr.Probability: 1.Severity: 3.Risk index: 3.Residual risk evaluation: a.New hazards: none.Mitigation(s) sufficient ;yes/ no? root cause: based on the investigation results the root cause of the carryover was confirmed to be due to a dirty flowcell.Conclusion: based on the investigation results the root cause of the carryover was confirmed to be due to a dirty flowcell.The fse performed a technical analysis and found that the failure was within the flowcell.They replaced the flowcell and sit flush hose, and aligned the lasers.After the adjustments, cqc and pqc tests were performed and the instrument was confirmed to be performing as expected.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk of this hazard has been identified to be within the acceptable level.H3 other text : see h10.
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It was reported that while running patient samples on bd facslyric¿ 3l10c instrument carryover occurred.There was no patient impact.The following information was provided by the initial reporter, translated from portugues to english: last wednesday ((b)(6) 2022) the equipment was performing properly and after monthly cleaning the equipment was clogged.The probe kept dripping, sit flush and clean cuvette not working, as has been the case for the last few months.Dr informed the team that the equipment had carryover and we were notified to start the investigation of the case.
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