|
It was reported that leakage of sheath fluid that was under pressure occurred with a bd facs¿lwa.The following information was provided by the initial reporter: it was reported that there is a persistent error "unacceptable vacuum leakage fault".Are there any forms that the fse will need to fill out prior to accessing your facility? no.Are there any screenings, such as temperature reading taken on site? no.Are they testing or running active c19 samples? yes.If yes, describe any known details.Not on the lwa but on adjacent lab systems.Are there any directives that the fse must follow that are not normal procedures? (shots up to date, flu shot, etc.) no.Is there any ppe provided by your organization? if so what? if not, what do we need to provide? yes.If provided, document applicable ppe.Lab coat & gloves.If required, then document what ppe bd needs to supply.Fse should bring his/her own respirator mask.Is your lab running any samples outside of a bio safety cabinet? yes.Are there any known active cases of c19 at your location? if yes, describe details.Yes but none she can think of.Are you using this product for clinical diagnostic tests? yes.Additionally, on 2020-05-12 the bd sales consultant provided the following additional information: was the customer/bd personnel physically in contact with the fluid? which part of the body was in contact to the fluid? what ppe was being worn? was customer harmed/injured? regarding leaking reportability question: fse replied on 05/12/2020 : the spray fluid was under pressure and it was sheath fluid.Issue 1: unacceptable vacuum leakage fault ((b)(4)).Issue 2: intermittent tube engagement fault.((b)(4)).Issue 3: accumulation of crystallized chunks of pbs buffer.((b)(4)).Additionally, on 2020-05-13 the bd sales consultant provided the following additional information: fse replied : no.Fse had gloves and mask on during service activity so no part of body comes in contact with any fluid directly.Customer was not harmed or injured.
|
|
The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-05-11.H.6.Investigation summary ¿ scope of issue: the scope of issue is only limited to part # 337408 and serial # (b)(6).¿ problem statement: customer reported complaint on an lwa including external tank option- 337408 of an unknown-persistent error "unacceptable vacuum leakage fault".The spray fluid (sheath) was under pressure.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 01may2019 to date 01may2020.¿ complaint trend: this is the only complaint related to this issue, 1554923.Date range from 01may2019 to date 01may2020.¿ manufacturing device history record (dhr) review: review of dhr part # 337408 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 3 servicemax work orders, the complaint trend, defect trend, dhr, root cause and the risk analysis, there were a few contributing factors to the safety complaint of spraying sheath fluid under pressure.The fse (field service engineer) confirmed that one part of the cause was due to pressure build up from a clog in the cell washer shroud tubing line going to v10 valve on valve stack also partially clogging the valve.This pressure forced sheath fluid to spray through an already worn out bal seal.Although the sheath fluid was under pressure, it was contained within the instrument and there was no injury to the customer or user.This leak was also partially responsible for the unacceptable vacuum leakage error.The other issue of intermittent tube engagement fault was caused by the poor vacuum in the system and not entirely related to spraying of fluid.Pbs (phosphate-buffered-saline) buffer crystallization was found accumulated inside the waste tank as well as on the waste tank probe, partially clogging probe opening, causing back pressure in waste lin.This interferes with the waste pump operation resulting into total loss of vacuum momentarily also contributing to tube engagement fault errors.The crystallization is not hazardous and is a low safety risk but the fse had requested the customer to have them replaced for precautionary measures, stated in sample management task #1574268.The fse also stated in the event description in trackwise, ¿crystallization is a result of customer maintenance and not a product defect.The salt is an artifact of the sheath that we run through the instruments.¿.The fse performed an extensive amount of repairs including replacing the barb fitting on cell washer shroud, cleared the capillary pathway, removed the clog, replaced the valve stack assembly as v9/v10 valves, rebuilt the cell washer head, replaced the 4th stage face seal block, replaced the cell washer assembly, replaced the waste tank, waste tank pump, waste level sensor tubing assembly, and calibrated the instrument.After the repairs, the instrument was rebooted, tested, and was functioning as expected.The safety risk is low because there was no impact to customer and health or safety.¿ service max review: review of related work order(s) #: (b)(4), (b)(4)& (b)(4)(case #(b)(4)) install date: (b)(6) 2019.Defective part number: 64971307 - kit upgrd pm lwa.64861717 - assembly cell wash mechanism svc blue.64845019 - assy valve stack blue repaired.346340 - pump liquid 1/8 barb.Work order notes for (b)(4): o subject / reported: persistent error "unacceptable vacuum leakage fault".O problem description: caller states she's already communicated this issue to fse k.Sheth who committed to be onsite to investigate next week.Telephone support declined in favor of onsite service.O work performed: fse replaced the barb fitting on cell washer shroud, cleared the capillary pathway with the help of a syringe, removed the clog.Fse replaced the valve stack assembly as v9/v10 valves were suspected to have been partially clogged.Fse rebuild the cell washer head, replaced the 4th stage face seal block as it was leaking/splashing fluid all over.Performed vacuum calibration and vacuum leakage test successfully, the vacuum improved in the system but intermittent tube engagement fault persisted on intermittent basis.Fse replaced the cell washer assembly with a repaired one.Vacuum improved and got better, cell washer alignment with respect to carousel rack was bit off causing friction, tube engagement fault still persisted as there was sudden total loss in vacuum in the system.Fse then replaced the cell washer assembly with a brand new one.Also found crystallized chunks of pbs buffer mixed with anti-foam solution inside the waste tank that also partially clogged the waste probe stem causing waste pump turn off momentarily due to back pressure.Replaced the waste tank along with waste level sensor tubing assembly from spare stock.Replaced waste pump, re-calibrated vacuum and ran leakage test.The vacuum level is very stable now in the system as cell washer picks up the tube for washing, waste pump does not turn off anymore.Fse ran reliability test on about 200 tubes with no errors.The escalation wo has been open to investigate accumulation of crystallized chunks of pbs buffer inside waste tank which also appears on other two units.O cause: user reported "unacceptable vacuum leakage fault" and "tube engagement fault" on frequent basis during sample wash run, there was an overall poor vacuum in the system due to clog in the cell washer shroud tubing line going to v10 valve on valve stack also partially clogging the valve, also fse found pbs buffer crystallized accumulation inside waste tank as well as on waste tank probe (it partially clogged the probe opening) that was causing back pressure in waste line and interfering with waste pump operation resulting into total loss of vacuum momentarily also contributing to tube engagement fault errors.O solution: the reported issue has been resolved and instrument is operating normally.The software version is 3.2 and defective cell wash assy.And valve stack assy.Will be shipped back to san jose.Customer not available for signature on date.Work order notes for (b)(4): o subject / reported: assist call - persistent error "unacceptable vacuum leakage fault".O problem description: assist call - caller states she's already communicated this issue to fse k.Sheth who committed to be onsite to investigate next week.Telephone support declined in favor of onsite service.O work performed: tightened electrical connections on waste pump.Adjusted power supply voltage to 28.05.Monitored vacuum (voltage) for several racks without an error.Customer will monitor verified instrument performance.O cause: could not reproduce issue while on-site.O solution: tightened electrical connections on waste pump.Adjusted power supply voltage to 28.05.Monitored vacuum (voltage) for several racks without an error.Customer will monitor verified instrument performance.Work order notes for (b)(4): (cancelled escalation).O subject / reported: assist call - persistent error "unacceptable vacuum leakage fault".O problem description: assist call - caller states she's already communicated this issue to fse k.Sheth who committed to be onsite to investigate next week.Telephone support declined in favor of onsite service.O work performed: n/a.O cause: n/a.O solution: n/a.¿ returned sample evaluation: the returned samples were shipped back to san jose.Upon evaluation with a service technician, the assembly part #¿s 64815018 and 94861718 were confirmed to be defective.¿ risk analysis: risk management file part #337146ra, rev #02 was reviewed.No new hazard have been identified and the current mitigations are sufficient.Hazard(s) identified? yes, no.O hazard id: 3.1.2.O hazard: 1.Un-prepped sample.2.No answer.3.Loss of sample.4.Safety-biohazard.O cause: defective valve o harmful effects: 1.Delayed or no results.2.2.Increased cost of test due to need to re-prep then rerun.3.Poor reliability.4.Blood exposure is higher risk without fixative.O risk control: 1.Visual color of sample.2.Customer check firmware error if valve stuck open.O implementation verification: eco1147e50487.O effectiveness verification: mini-pump/valve reliability test protocol and report systems level reliability test protocol and report.O probability: 1 o severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazard: none.Mitigation(s) sufficient yes, no.¿ root cause: based on the investigation results the root cause of the spray of sheath fluid was due to both a clog in the cell washer shroud tubing line going to v10 valve on valve stack and a worn out bal seal.¿ conclusion: based on the investigation results, the safety concern of sheath fluid spraying under pressure was due to both a clog in the cell washer shroud tubing line going to v10 valve on valve stack and a worn out bal seal.Vacuum leakage and intermittent tube engagement faults were partially related to the cause but not entirely.These issues were resolved by replacing parts, cleaning clogged or dirty areas, and recalibrating.After the repairs, the instrument was rebooted, tested, and was functioning as expected.The safety risk is low because there was no impact to customer health or safety.¿ supporting document: n/a.
|
|
It was reported that leakage of sheath fluid that was under pressure occurred with a bd facs¿lwa.The following information was provided by the initial reporter: it was reported that there is a persistent error "unacceptable vacuum leakage fault".1.Are there any forms that the fse will need to fill out prior to accessing your facility? no.2.Are there any screenings, such as temperature reading taken on site? no.3.Are they testing or running active c19 samples? yes.If yes, describe any known details.Not on the lwa but on adjacent lab systems.4.Are there any directives that the fse must follow that are not normal procedures? (shots up to date, flu shot, etc.) no.5.Is there any ppe provided by your organization? if so what? if not, what do we need to provide? yes.If provided, document applicable ppe.Lab coat & gloves.If required, then document what ppe bd needs to supply.Fse should bring his/her own respirator mask.6.Is your lab running any samples outside of a bio safety cabinet? yes.7.Are there any known active cases of c19 at your location? if yes, describe details.Yes but none she can think of.8.Are you using this product for clinical diagnostic tests? yes.Additionally, on 2020-05-12 the bd sales consultant provided the following additional information: -was the customer/bd personnel physically in contact with the fluid? -which part of the body was in contact to the fluid? -what ppe was being worn? -was customer harmed/injured? regarding leaking reportability question: fse replied on 05/12/2020 : the spray fluid was under pressure and it was sheath fluid.Issue 1: unacceptable vacuum leakage fault (1554923).Issue 2: intermittent tube engagement fault.(1567690).Issue 3: accumulation of crystallized chunks of pbs buffer.(1567702).Additionally, on 2020-05-13 the bd sales consultant provided the following additional information: fse replied : 1.No.2.Fse had gloves and mask on during service activity so no part of body comes in contact with any fluid directly.3.Customer was not harmed or injured.
|
