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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 # 338962, and serial # (b)(6) problem statement: customer reported a complaint regarding being unable to complete fluidic shutdown which caused a spray of fluid under pressure that occurred on 05jan2023.A spray or pressurized leak has the risk of biohazard exposure to the user of the instrument.The instrument was repaired and found to be functioning as expected.No users or patients were harmed or injured due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue for part # 338962.Date range from 05jan2022 to date 05jan2023.Manufacturing device history record (dhr) review: dhr part # 338962, serial # (b)(6), file #(b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 4 complaints related to the issue of spray of fluid caused by a mechanical problem (as reported code 1: ¿fluidic - leak¿; as analyzed code 1: ¿mechanical problem identified¿; as analyzed code 2: ¿leak - spray¿) for part # 338962; pr# (b)(4), (b)(4), (b)(4), and this one, (b)(4).Date range from 05jan2022 to date 05jan2023.Returned sample analysis: a return sample was not requested for evaluation because the replaced part is not returnable and was discarded.Service history review: review of related work order #: n/a; case #: (b)(4).Install date: (b)(6) 2014.Defective part number: n/a.Case comments: subject/reported: unable to complete fluidic shutdown.Problem description: unable to complete fluidic shutdown.On ((b)(6) 2023 8:43 am) issue: unable to complete fluidic shutdown.Steps taken with customer/troubleshooting: unable to complete fluidic shutdown.Customer says she believes it is only failing fluidic shutdown.Asked customer to check the shutdown solution filter.She confirmed it was dry.Customer was unable to find bypass tubing.Had customer manually fill facsshutdown filter with dih20.She installed the prefilled filter.Customer attempted fluidic start up and noticed the facs shutdown solution was empty.She replaced with a full container and performed more prime after tank refills.Customer performed fluidic start up and waste began shooting out.Asked the customer to loosen waste cap which stopped the spray.I asked if anyone was injured by the sprayed waste.Customer confirmed everyone was fine and the spray was small.Customer was unsure when the waste cap was last switched out.Informed customer the waste cap filter must be replaced monthly or when filter is wet.If not, the filter is unable to pass air thorough and can cause back pressure which is what happened here.Customer replaced the waste cap filter and fluidic shutdown occurred as expected.Let customer know she may use the canto today and then call back after a fluidic shut down is performed.On ((b)(6) 2023 8:45 am), customer performed the shutdown and now the system is working fine.They asked that we close this case and should they have any future issues they will call back.Labeling/packaging review: n/a.Risk analysis: risk management file part #338960-04ra, rev.01/vers.A, bd facscanto ii flow cytometer (fluidics) fmea (failure mode and effect analysis) was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes or no.Hazard id # (item): 6.Waste.Hazard (potential failure mode): 6.1.1 waste not contained.Harmful effects (potential effect(s) of failure): 6.1.1.1 biohazards.Cause (potential cause(s)/mechanism(s) of failure): 6.1.1.1.1 pressure build-up.Residual probability (occurrence): 9.Residual severity: 2.Residual risk index (rpn): 18.Potential causes: based on the investigation results, the potential cause was determined to be a worn waste cap filter.Investigation result/analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, the potential cause was determined to be a worn waste cap filter.In response to the customer reporting being unable to complete the fluidic shutdown, the tsr (technical service representative) asked the customer to check the shutdown solution filter and then fill the shutdown filter with di water since it was dry and install the pre-filled filter.Upon attempting fluidic startup, the customer noticed that the shutdown solution tank was empty and replaced it with a full container, but a spray of waste started shooting out after trying fluidic startup again.The tsr suggested loosening the waste cap which stopped the spray and advised the customer to replace the waste cap filter.If the waste cap filter is not replaced monthly or when wet, the filter cannot pass air through, thus causing a buildup of pressure which can result in a spray of fluid.After the customer replaced the waste cap filter, they were able to perform the fluidic shutdown correctly, and they confirmed that the instrument was functioning as expected with no further sprays.Although there was a spray of fluid under pressure not contained within the instrument, the customer confirmed that it was a small spray.Moreover, the waste tank, which was the source of the spray, was empty except for bleach and reagents used for fluidic startup, thus minimizing the exposure to biohazardous material.The customer also confirmed that no user came in physical contact with the sprayed fluid, and no one was harmed or injured.Bd facscanto¿ flow cytometer instructions for use (ifu), #23-14730-03 rev.01/vers.A, indicates to wear suitable protective clothing and gloves to prevent transmission of potentially fatal disease from biological specimens.This can be found on page 147 in cleaning the surfaces.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation results, the complaint was confirmed and the potential cause of the customer not being able to perform fluidic shutdown which resulted in a spray of fluid under pressure was determined to be a worn waste cap filter.The tsr walked the customer through troubleshooting and repairs and identified that the waste cap filter had not been replaced in a while, which was causing a pressure buildup resulting in a spray of fluid.The customer replaced the waste cap filter, and confirmed that they were able to successfully complete the fluidic shutdown without any sprays.The instrument was confirmed to be functioning as per bd specifications.No one was harmed or injured due to the spray of fluid.The safety risk of this hazard has been identified to be within the acceptable level.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.Supporting document: n/a.
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