It was reported that bd facscalibur¿ flow cytometer was leaking outside of the instrument.There was no report of patient impact.The following information was provided by the initial reporter.Instrument leaking.Leak checklist: was the leak liquid or air? liquid , was the leak contained within the instrument? not contained,was there spray of liquid? no, what was the fluid that leaked? unknown , did biohazard leak before or after waste line? after waste line, was the waste mixed with decontaminate/bleach? no, was the customer/ bd personnel physically in contact with the fluid? no.
|
H.6 investigation summary: investigation summary: ¿ scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, serial # (b)(6).¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 13jun2021 to 13jun2022.¿ complaint trend: there were 3 complaints related to waste leakages due to clogged tubings; pr# (b)(4).Date range from 13jun2021 to 13jun2022.¿ manufacturing device history record (dhr) review: dhr part #342975 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 clogged dcm (droplet containment module) line.This line is used to help aspirate waste to the waste tank, but any clogs or debris will contribute to leaks or backflow.The fse found that the leakage was due to a clogged section of the dcm tubing (pn 343585) and replaced the tubing.After the repair the instrument was tested and was performing as expected with no further leaks.No parts were requested for evaluation as the replaced part is not returnable and was discarded.Additionally, the leakage was not in the form of a spray and thus did not significantly increase the risk of exposure.Even though patient samples were used for clinical use, no patient was treated nor harmed from any erroneous results.The results were captured prior to any diagnosis decision and no report of delay in patient treatment.Proper daily and monthly cleaning and maintenance can help in maintaining an optimal system, and can be found in the bd facscalibur¿ instructions for use, 23-12911-02 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 #: (b)(4), case # (b)(4) install date: (b)(6) 2008 defective part number: 343585 work order notes: o subject / reported: instrument leaking o problem description: instrument leaking o work performed: replaced the clogged section of tubing (nsi pn 343585.) verified operation of the dcm.O cause: sip is dripping due to clogged dcm tubing between the flowcell and the dcm pump.O solution: the reported leak was resolved by replacing the clogged section of dcm tubing.The instrument is operating as intended and is testing without errors.I have returned the instrument to the lab for normal use.¿ 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 # 342973-01ra, rev.01/vers.A, bd facscalibur failure mode and effect analysis was reviewed.The current mitigations are adequate with rpn under acceptable range.Hazard(s) identified? yes no o item: droplet containment module o function: to contain droplets o potential failure mode: droplets not contained o potential effects of failure: all of the sample is o potential causes/mechanisms of failure: pump not properly sealed o current controls: n/a o recommended actions: n/a o responsible party: n/a o target completion date: n/a o actions taken: n/a o sev: (b)(4) o occ: (b)(4) o det: (b)(4) o rpn: (b)(4) 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 clogged dcm line.¿ conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a clogged dcm line.The fse confirmed the issue and replaced the clogged section of the tubing (pn 343585).After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no further leaks occurred.The safety risk of this hazard has been identified to be within the acceptable level.¿ supporting document: n/a.
|