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It was reported that while running bd facscanto ii cytometer 4/2 system ivd leaked biohazard waste.There was no user impact.The following information was provided by the initial reporter: was the leak fluid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? facsclean was leaking out of a connector at the filter.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontamination or bleach? was the customer/bd personnel physically in contact with the fluid? no.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin.".
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H6: investigation summary scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2/2 sys ivd part # 338960, serial # (b)(6).Problem statement: customer reported complaint of a leakage of biohazard not contained within the instrument.Manufacturing defect trend: there are (b)(4) qns (quality notifications) related to the reported issue.Date range from 31aug2020 to 31aug2021.Complaint trend: there are (b)(4) complaints related to the issue of leakage of biohazard not contained within the instrument.Date range from 31aug2020 to 31aug2021.Manufacturing device history record (dhr) review: dhr part # 338960 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 connector.The customer had initially submitted a complaint regarding facsclean leaking out of the wet cart.An fse (field service engineer) was brought onsite for the repair, and they identified the source of the leakage to be a facsclean filter waste connector within the wet cart.The connector was replaced (pn 33304507) and a leak test was performed to verify the instrument was no longer leaking.No parts were requested for evaluation as the replaced part is not returnable and was discarded.After the repair the instrument was tested and confirmed to be performing as expected.Although the leakage of biohazard poses a risk of contamination if there is skin contact, the customer confirmed that they had not come in contact with the leakage.Additionally, there was no spray of fluid so the risk of exposure was minimal.While this instrument was being used for clinical diagnoses, the customer confirmed that the results gathered during the incident were not used and the patient was not affected in any way.The safety risk is limited, s2, and there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2012.Defective part number: n/a.Work order notes: o subject / reported: 338960 - bd facscanto ii cytometer 4/2 system ivd - facsclean has expired from the wet cart.O problem description: the complete facsclean ran out of the wet cart via nach.O work performed: troubleshooting carried out; wet card open; the connector on the facsclean filter is leaking; connector renewed (pn: 33304507); leak test carried out; startup carried out; optics checked; 7-color setup carried out: ok; device ok.O cause: connector leaking.O solution: failure had no effect on customer samples; the customer has not come into contact with the facsclean.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 #338960-04ra, version a, bd facscanto ii flow cytometer (fluidics) fmea was reviewed.The severity rating in this file is ¿9¿ and the rpn is ¿18¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, whereby the biohazard exposure is obvious or indicated by additional (warning) information and hence the impact to the customer is negligible to none.The current mitigations are adequate with rpn under acceptable range.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.O item: 6.Waste.O function: 6.1 contain waste.O potential failure mode: 6.1.1 waste not contained.O potential effect(s) of failure: 6.1.1.1 biohazards.O potential cause(s) / mechanism(s) of failure: 6.1.1.1.2 waste container overflows.O current controls: level sensor.O recommended actions: n/a.O responsible party: n/a.O target completion date: n/a.O actions taken: n/a.O sev: 9.O occ: 2.O det: 1.O rpn: 18.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a worn waste connector.Conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a worn waste connector.The fse confirmed the issue was from a worn waste connector on the wetcart¿s facsclean filter.The fse replaced the part, tested the instrument, and confirmed that it was functioning as expected.No one was harmed or injured, and no medical treatment was performed due to the biohazardous leak.The safety risk is limited, s2, and there was no impact to customer health or safety.
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It was reported that while running bd facscanto ii cytometer 4/2 system ivd leaked biohazard waste.There was no user impact.The following information was provided by the initial reporter: was the leak fluid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? facsclean was leaking out of a connector at the filter.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontamination or bleach? was the customer/bd personnel physically in contact with the fluid? no.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin.".
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