MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCOUNT INSTRUMENT SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	337858
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that waste leakage occurred outside of instrument with a bd facscount¿ instrument system.The following information was provided by the initial reporter: leakage has been reported by the user.Was the leak contained within the instrument? no, the liquid was dripping out of the instrument.Was the leak in a customer accessible location? yes, the customer could wipe put the dripping liquid from the surface of the instrument bench.Was there spray of fluid under pressure? no, there was no spraying; only droplets under low pressure.What was the fluid that leaked? waste fluid.What is the source of leak -- waste line or non-waste line? from the worn out vacuum pump along the waste line.If waste line, whether it is mixed with bleach or contamination? no, it was not while it was flowing in the waste line tubing and the fluid only got into contact with bleach when it ended up in the waste tank filled with the bleach solution.Users confirmed they wear ppes always.Was the customer exposed to blood or bodily fluids? no, the customer worn protective equipment when handling the instrument and leaking fluid.Was there any physical harm to the customer as a result of the leak? no, the was no any physical harm.
Event or Problem Description
It was reported that waste leakage occurred outside of instrument with a bd facscount¿ instrument system.The following information was provided by the initial reporter: leakage has been reported by the user.1.Was the leak contained within the instrument? no, the liquid was dripping out of the instrument.2.Was the leak in a customer accessible location? yes, the customer could wipe put the dripping liquid from the surface of the instrument bench.3.Was there spray of fluid under pressure? no, there was no spraying; only droplets under low pressure.4.What was the fluid that leaked? waste fluid.5.What is the source of leak -- waste line or non-waste line? from the worn out vacuum pump along the waste line.6.If waste line, whether it is mixed with bleach or contamination? no, it was not.While it was flowing in the waste line tubing and the fluid only got into contact with bleach when it ended up in the waste tank filled with the bleach solution.Users confirmed they wear ppes always.7.Was the customer exposed to blood or bodily fluids? no, the customer worn protective equipment when handling the instrument and leaking fluid.8.Was there any physical harm to the customer as a result of the leak? no, the was no any physical harm.
Additional Manufacturer Narrative
H6 investigation summary: scope of issue: the scope of issue is only limited to bd facscount instrument system part # 337858, serial # (b)(6).Problem statement: customer reported complaint of a waste leakage, without bleach, not contained within the instrument.Manufacturing defect trend: there are no other qns (quality notifications) related to the reported issue.Date range from 06oct2019 to date 06oct2020.Complaint trend: this is the only complaint related to the issue of waste leakage not contained within the instrument.Date range from 06oct2019 to date 06oct2020.Manufacturing device history record (dhr) review: dhr part #337858 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 leak not contained within the instrument was due to a worn vacuum pump.The function of the pump is to aspirate and move waste to the waste tank.The fse (field service engineer) confirmed the leak coming from the diaphragm of the pump and replaced it the unit, part #05-10748-00 - pump liquid 15psig continous 12vdc.The fse also performed an optical alignment, system verification test and checked all parameters.The instrument successfully passed all controls and samples.No return sample was requested because the replaced part is not returnable and was discarded.Although the leak was waste and the potential exposure to biohazard material, there was no skin contact nor was there any medical treatment performed.No user was harmed or injured as they were wearing proper ppe (personal protective equipment) to clean up the leak, per pr# 1896127 - wfi-intake-safety alignment.In addition, there was no spray of fluids whereas the pressure was very low.After the repairs and adjustments, the instrument was rebooted, tested and functioning as expected.The safety risk is low, 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: 08jun2014.Defective part number: 05-10748-00 - pump liquid 15psig continous 12vdc work order notes: subject / reported: 337858 - bd facscount instrument system leakage.Problem description: leakage has been reported by the user.Engineer should provide more details work performed: 07.Oct.2020; contacted user (b)(6) confirms that there is an internal system leakage of fluid from below, the machine is turned off and not in use since last friday.Visited the site, checked the system and confirm that the vacuum pump will need replacement as it is worn out hence leaking from the diaphragm.To plan another visit once the part is available.08.Oct.2020; replaced backflash pump (vacuum pump pn.C051074800).Performed optical alignment as well as system verification tests.Checked and verified system, confirmed okay within parameters.Successfully ran prepared controls which passed.Successfully ran prepared samples.Left the instrument working as required.Cause: internal system leakage.Solution: make site visit.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 # 337858ra, rev.02, bd facscount risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes, no.Id: 3.1.3 hazard: functional hazard, cause: faulty vacuum pump, harmful effects: excess air in the system, risk control: bd facscount system user¿s guide (ref: 337842 rev a).Technical support form field service engineer (fse).Implementation verification: refer to ¿priming the system¿ section of user guide 337842 rev a (page 44).Effectiveness verification: release of user guide 337842.Probability: 1, severity: 2, risk index: 2, residual risk evaluation: a, new hazards: none.Mitigation(s) sufficient: yes, no.Root cause: based on the investigation results the root cause was due to a worn vacuum pump.Conclusion: based on the investigation results, the root cause of the waste leak, not contained within the facscount, was due to a worn vacuum pump.The fse confirmed the issue, replaced the part and brought the instrument to normal operation.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical treatment was given for biohazard exposure.The safety risk is low as there was no impact to customer health or safety.H3 other text : see h10.

• Brand Name: BD FACSCOUNT INSTRUMENT SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10740622
• Report Number: 2916837-2020-00210
• Device Sequence Number: 19650213
• Product Code: GKZ
• UDI-Device Identifier: 00382903378586
• UDI-Public: 00382903378586
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K933486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 337858
• Device Catalogue Number: 337858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1