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H.6 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 complaint regarding carry over.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 05may2021 to date 05may2022.Complaint trend: there are 8 complaints related to the issue of high carry over: date range from 05may2021 to date 05may2022.Manufacturing device history record (dhr) review: dhr part #659180 serial # (b)(6), 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 carryover between sample tests was due to failures within the sample line, sit flush pump, drain line restrictor, and v1, v3, and v4 valves.The customer had initially reported the carryover and noted that the sit flush settings were set to 1 flush between each tube.Upon arrival, the fse (field service engineer) was able to confirm issue and began the repair by replacing the sample line, p1 sit flush pump, drain line restrictor and v1, v3 and v4.The fse then added 2 sit flushes between each tube.After the repair the instrument was tested using a cs&t test and it and was performing as expected.No parts were requested for evaluation as the replaced parts are not returnable.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 did not impact the patient at all.Proper daily and monthly cleaning procedures can reduce the occurrence of carryover and be found under ¿maintenance¿ in the user guide; bd facslyric¿ clinical system instructions for use, #23-19938-02 rev.1/vers.A, page 165.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: 02453206, 02437908, case # (b)(4).Install date: 28aug2018.Defective part number: 641925 - pump priming p2 main system.652786 - liberty ruo pm kit.647945 - orifice-restrictor.020in dia blue.647991 - assy valve-1 with labels.647994 - assy valve-4 with labels.647993 - assy valve-3 with labels.Work order notes: subject : 659180 - facslyric - elevated cross-contamination.Problem description: customer has noted to suspect elevated cross contamination between tubes.When acquiring tubes with water after an earlier tube with sample, the water sample is showing remaining signal of the earlier ran tube.Sit flush settings are set to 1 sit flush between tubes.Work performed: _replacement of the sample line._replacement of the p1 sit flush pump._replacement of the drain line restrictor._replacement of v1,v3,v4._addition of 2 sit flushes between each tube.Passage ball cst ok.Automaton consistent with use.Cause: sample line and sit flush.Solution: replacing parts and adding 2 more sit flushes solved the problem.Returned sample evaluation: a return sample was not requested because the replaced parts are not returnable.Risk analysis: risk management file part # 10000063058ra, 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 or no? azure id: (b)(6).Id: libivd-ra-102 3.1.8.Reg status: ivd; ruo.Hazard: incorrect output.Cause: sample carryover error - electronic.Harmful effects: events appear in wrong tube (false positive result).Risk control: data buffer will be purged between sample acquisitions.System level carryover test.Req link (azure id): (b)(6).Libivd-fw-471 data carry over.Implementation verification: cmsvp-aq-data_format.Liberty libivd-15-09p.Effectiveness verification: liberty cms firmware subsystem verification summary report.Libivd-15-09f.Probability: 1.Severity: 3.Risk index: 3.Residual risk evaluation: a.New hazards: none.Azure id: (b)(6).Id: libivd-ra-256 3.1.34.Reg status: ivd; ruo.Hazard: incorrect data.Source: flow cell fmea.Cause: tubing or port detail diameters at spec extremes, causing misalignment.Harmful effects: 1.Unacceptable carryover.2.Potential incorrect results.Risk control: sample carryover testing to confirm the sample carryover level to specifications.Req link (azure id): n/a.Implementation verification: lsvn-1013-dp sample carryover.Effectiveness verification: lsvn-1013-dr.Probability: 1.Severity: 3.Risk index: 3.Residual risk evaluation: a.New hazards: none.Mitigation(s) sufficient: yes or no? root cause: based on the investigation results the root cause of the carryover between sample tests was due to failures within the sample line, sit flush pump, drain line restrictor, and v1, v3, and v4 valves.Conclusion: based on the investigation results the root cause of the carryover between sample tests was due to failures within the sample line, sit flush pump, drain line restrictor, and v1, v3, and v4 valves.The fse confirmed the issue and replaced the sample line, p1 sit flush pump, drain line restrictor, and v1, v3, and v4 valves.The fse also added an additional 2 sit flush operations between each tube.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 any incorrect results.The safety risk of this hazard has been identified to be within the acceptable level.Supporting document: n/a.
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