MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿; FLOW CYTOMETRIC REAGENTS AND ACCESS

Model Number	662878
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while running bd facslyric¿ waste leaked outside of the instrument.There was no patient or user impact.The following information was provided by the initial reporter: it was reported by the customer that there is a possible pump issue.Was there a fluidic leak or spill? yes.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? yes.What was the fluid that leaked/spilled? sheath.What is the source of leak/spill? sampleline.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.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.
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.
Additional Manufacturer Narrative
H.6.Investigation: ¿ scope of issue: the scope of issue is only limited to facslyric 3l10c instrument us, part # 662878, serial # (b)(6).¿ problem statement: customer reported complaint regarding a leakage of biohazard not contained within the instrument.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 08feb2021 to date 08feb2022.¿ complaint trend: there are (b)(4) complaints related to a leakage of biohazard not contained within the instrument.Date range from 08feb2021 to date 08feb2022.¿ manufacturing device history record (dhr) review: dhr part #662878, serial # (b)(6), file # (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 the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the biohazard leak was due to an improperly installed flowcell, check valve, and tubing.The customer had initially reported that liquid was leaking from the sit, the manual port would not aspirate properly, and air bubbles appeared at the top of the flowcell.An fse came onsite for the repair and identified the issue along with a voltage issue.The fluidic motherboard was replaced to resolve this voltage issue, and the part was not requested for evaluation as it was not related to the leakage.The fse discovered that a third party had attempted to swap the flowcell and check valve but had installed it improperly.The fse cleaned and regelled the components and reinstalled the flowcell, flowcell tubing, and check valve.After the repair the instrument was tested and functioning as expected.Although a leakage of waste material poses a hazard of contamination upon contact, the customer confirmed that they were not harmed in any way.Additionally, the leakage was not under pressure and thus did not increase the risk of exposure.This instrument was not being used for clinical tests at the time of the incident and thus did not have any impact on any patients.Proper daily and monthly cleaning and maintenance can help in maintaining an optimal system, and can be found in the 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 #: (b)(6), case # (b)(6).Install date: 27feb2020.Defective part number: 64551640 - pcb assembly fluidic work order notes: o subject / reported: email: possible pump issue o problem description: we are not 100% is the pump issue or other part is malfunction.Please see attached video.There are vids from tina hou in the cts inbox.Issue we have: solution is leaking out from the manual port.During monthly clean, the manual port won¿t take the solution from tube.Lot of air bubble in the tubing o work performed: problem 1.Found no voltage was being supplied to the p2 pump.Replaced the fluidic motherboard.Problem 2.Also found the flowcell needed a lot of attention.Third party had tried swapping and installed incorrectly.Tubing was not installed correctly to it, check valve was in the wrong direction, and needed to be cleaned and re-gelled.The instrument is and running and passed verification.O cause: problem 1.Found no voltage was being supplied to the p2 pump.Replaced the fluidic motherboard.Problem 2.Also found the flowcell needed a lot of attention.Third party had tried swapping and installed incorrectly.Tubing was not installed correctly to it, check valve was in the wrong direction, and needed to be cleaned and re-gelled.The instrument is and running and passed verification.O solution: problem 1.Found no voltage was being supplied to the p2 pump.Replaced the fluidic motherboard.Problem 2.Also found the flowcell needed a lot of attention.Third party had tried swapping and installed incorrectly.Tubing was not installed correctly to it, check valve was in the wrong direction, and needed to be cleaned and re-gelled.The instrument is and running and passed verification.¿ returned sample evaluation: a return sample was not requested because the part that was replaced was related to a voltage issue and did not relate to the leakage.¿ risk analysis: risk management file part # (b)(6), rev.07/vers.Aa, 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: (b)(4).O id: (b)(4).O reg status: ivd; ruo.O hazard: exposure to biological sample.O cause: back drip from injection port (sit).O harmful effects: harm to operator.(exposure to stained sample).O risk control:.- sit design to capture back drips.- provide instruction for universal precautions.O req link (azure id): (b)(4) sample preservation during pause.O implementation verification: - lsvn-1008-dp sit backflow control.- (b)(4).O effectiveness verification: - lsvn-1008-dr.- (b)(4).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 biohazard leakage not contained within the instrument was due to an improperly installed flowcell, tubing, and check valve.¿ conclusion: based on the investigation results the root cause of the biohazard leakage not contained within the instrument was due to an improperly installed flowcell, tubing, and check valve.The fse confirmed the issue and adjusted the flowcell, tubing and check valve to their correct position.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk of this hazard has been identified to be within the acceptable level.H3 other text : see h.10.
Event or Problem Description
It was reported that while running bd facslyric¿ waste leaked outside of the instrument.There was no patient or user impact.The following information was provided by the initial reporter: it was reported by the customer that there is a possible pump issue.Was there a fluidic leak or spill? : yes.1.Was the leak/spill contained within the instrument no.2.Was the leak/spill in a customer accessible location? : yes.3.What was the fluid that leaked/spilled? sheath.: 4.What is the source of leak/spill?: sampleline.5.Was the customer exposed to blood or bodily fluids?: no.6.Was there any physical harm to the customer as a result of the leak: no.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.
Additional Manufacturer Narrative
H.10.After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.(leakage of non-biohazard (ethanol, sheath fluid) under no pressure) is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while running bd facslyric¿ waste leaked outside of the instrument.There was no patient or user impact.The following information was provided by the initial reporter: it was reported by the customer that there is a possible pump issue.Was there a fluidic leak or spill? yes.1.Was the leak/spill contained within the instrument no.2.Was the leak/spill in a customer accessible location? yes.3.What was the fluid that leaked/spilled? sheath.4.What is the source of leak/spill? sampleline.5.Was the customer exposed to blood or bodily fluids? no.6.Was there any physical harm to the customer as a result of the leak no.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.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13588617
• Report Number: 2916837-2022-00038
• Device Sequence Number: 14930736
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: 00382906628787
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2022

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: 662878
• Device Catalogue Number: 662878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 07/29/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/21/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown