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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿; FLOW CYTOMETRIC REAGENTS AND ACCESS
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| Model Number 662878 |
| Device Problems
Contamination (1120); Fluid/Blood Leak (1250)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/01/2022 |
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Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that while running bd facslyric¿ carryover of patient samples occurred.The carryover fluid also leaked outside of the instrument.Customer was exposed to the leakage, however, there was no negative impact reported.The following information was provided by the initial reporter: sit leaking, causing carryover are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.¿were erroneous results reported and used to treat a patient? no¿.¿yes the customer was exposed to drips of fluid that were on the bench top just beneath the sit.The amount of fluid that dripped was approximately 50ul and the contents of the fluid leaked is unknown probably mainly sheath but there could be carry over from other samples but the absolute contents of the sit flush could be categorized as unknown.¿.
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Manufacturer Narrative
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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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Event Description
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It was reported that while running bd facslyric¿ carryover of patient samples occurred.The carryover fluid also leaked outside of the instrument.Customer was exposed to the leakage, however, there was no negative impact reported.The following information was provided by the initial reporter: sit leaking, causing carryover are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.¿were erroneous results reported and used to treat a patient? no¿.¿yes the customer was exposed to drips of fluid that were on the bench top just beneath the sit.The amount of fluid that dripped was approximately 50ul and the contents of the fluid leaked is unknown probably mainly sheath but there could be carry over from other samples but the absolute contents of the sit flush could be categorized as unknown.¿.
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Manufacturer Narrative
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H6: investigation summary: ¿ scope of issue: the scope of issue is only limited to facslyric 3l10c instrument us, part # 662878, 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 01feb2021 to date 01feb2022.¿ complaint trend: there are 6 complaints related to the issue of high carry over; date range from 01feb2021 to date 01feb2022.¿ manufacturing device history record (dhr) review: dhr part #662878 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 loose pinch valve tubing.The pinch valve contributes to the aspiration of fluids and failures of this part can contribute to carryover and leakages outside of the instrument.The customer had reported that the sit was dripping after the sit flush operation and found that the pinch tubing was loose and could not be adjusted due to tie wraps.The tsr (technical service representative) in contact with the customer recommended the customer to move or cut the pinch valve so they could access the tie wrap, and the customer eventually reported that they were able to adjust the pinch valve tubing.After the repair the instrument was reported to be functioning as expected.No parts were requested for evaluation as there were no parts replaced.This instrument was not being used for the clinical diagnosis of any patients at the time of this incident and thus the erroneous results did not have any effect on any patients.The customer also reported that there was a fluid leakage not contained within the instrument, but no one came in contact or was harmed by the leakage.Additionally, the leakage was not under pressure and thus did not increase the risk of exposure.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 #: n/a, case # (b)(4).Install date: (b)(6) 2018.Defective part number: case comments: o ((b)(6) 2022 4:57 am): reviewed, all info present.O ((b)(6) 2022 1:56 pm): customer was able to resolve the issue with the sit flush leaking by re seating the pinch valve tubing.O ((b)(6) 2022 10:11 am): reviewed, pending customer follow-up.O ((b)(6) 2022 8:24 am) spoke to (b)(6) and she stated that thy are experiencing dripping after sit flushes and that they have checked v8 and the pinch tubing cannot be placed back into the valve all the way do to some type of tie wrap that is in the way a little.I asked the customer if they could move it or cut it but they are unsure.I will reach out to the fse and most likely dispatch this case but i will try and get a little information.Are you using this product for clinical diagnostic test? no.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? no.Follow up required? no.Software version? no.List of parts shipped (include foc): no.Rma required? no.Was there a fluidic leak or spill? yes.1.Was there spray of fluid under pressure? no.2.Was the leak/spill contained within the instrument? no.3.Was the leak/spill in a customer accessible location? yes.4.What was the fluid that leaked/spilled? unknown.5.What is the source of leak/spill? (waste or non-waste line) inknown.6.Was the customer exposed to blood or bodily fluids? uknown.7.Was there any physical harm to the customer as a result of the leak no.O ((b)(6) 2022 8:14 am) customer problem: sit leaking, causing carryover.O ((b)(6) 2022 8:07 am) sit leaking causing carryover.¿ returned sample evaluation: a return sample was not requested because no parts were replaced.¿ risk analysis: risk management file part # 10000063058ra, rev.06/vers.Z, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.O azure id: 89171.O id: libivd-ra-63 2.1.8.O reg status: ivd; ruo.O hazard: exposure to biological sample.O cause: back drip from injection port.O harmful effects: wrong results by cross contamination.O risk control: design to ensure that there is no back drip.Automatic sit flush to minimize carryover between tubes.O req link (azure id): 93132 libivd-did-262 sample preservation during pause.O implementation verification: lsvn-1008-dp sit backflow control, libivd-se-15-72p.O effectiveness verification: lsvn-1008-dr, libivd-se-15-72f.O probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.O azure id: 89236.O id: libivd-ra-256 3.1.34.O reg status: ivd; ruo.O hazard: incorrect data.Source: flow cell fmea o cause: tubing or port detail diameters at spec extre.Mes, causing misalignment.O harmful effects: unacceptable carryover, potential incorrect results o risk control: sample carryover testing to confirm the sample carryover level to specifications.O req link (azure id): n/a o implementation verification: lsvn-1013-dp sample carryover.O effectiveness verification: lsvn-1013-dr.O probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.Mitigation(s) sufficient yes no.¿ root cause: based on the investigation results the root cause of the carryover between sample tests was due to a loose pinch valve tubing.Conclusion: based on the investigation results the root cause of the carryover between sample tests was due to a loose pinch valve tubing.The customer was able to identify and resolve the issue by adjusting the pinch valve tubing before an fse was sent onsite.After the repair, the instrument was reported to be functioning as expected.No one was harmed or injured as there was no contact with the waste leakage, and no medical diagnosis was performed as the instrument was not running being used for clinical tests at the time.The safety risk of this hazard has been identified to be within the acceptable level.H3 other text : see h10.
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Event Description
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It was reported that while running bd facslyric¿ carryover of patient samples occurred.The carryover fluid also leaked outside of the instrument.Customer was exposed to the leakage, however, there was no negative impact reported.The following information was provided by the initial reporter: sit leaking, causing carryover are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.¿were erroneous results reported and used to treat a patient? no¿ ¿yes the customer was exposed to drips of fluid that were on the bench top just beneath the sit.The amount of fluid that dripped was approximately 50ul and the contents of the fluid leaked is unknown probably mainly sheath but there could be carry over from other samples but the absolute contents of the sit flush could be categorized as unknown.¿.
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