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

Model Number 338960

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while using bd facscanto¿ sheath fluid sprayed outside of instrument.The following information was provided by the initial reporter: leaking unknown fluid from back of wetcart.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.Was there spray of fluid under pressure? yes.What was the fluid that leaked? unknown.What is the source of leak -- waste line or non-waste line? unknown.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.Additionally, the fse provided the following additional information: the sheath fluid tube had chaffed against the metal casing of the wet cart and was cut.Replaced the tubing with a non stock and test all okay.Run cst pass.Run multiple fluidic startups.All okay.Return machine back to customer in good working condition.Leaking sheath fluid from back of wetcart.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.Was there spray of fluid under pressure? yes.What was the fluid that leaked? sheath fluid.What is the source of leak -- waste line or non-waste line? cut in sheath tubing.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.

Event Description

It was reported while using bd facscanto¿ sheath fluid sprayed outside of instrument.The following information was provided by the initial reporter: leaking unknown fluid from back of wetcart.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.Was there spray of fluid under pressure? yes.4.What was the fluid that leaked? unknown.5.What is the source of leak -- waste line or non-waste line? unknown.6.Was the customer exposed to blood or bodily fluids? no.7.Was there any physical harm to the customer as a result of the leak? no.Additionally, the fse provided the following additional information: the sheath fluid tube had chaffed against the metal casing of the wet cart and was cut.Replaced the tubing with a non stock and test all okay.Run cst pass.Run multiple fluidic startups.All okay.Return machine back to customer in good working condition.Leaking sheath fluid from back of wetcart.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.Was there spray of fluid under pressure? yes.4.What was the fluid that leaked? sheath fluid 5.What is the source of leak -- waste line or non-waste line? cut in sheath tubing.6.Was the customer exposed to blood or bodily fluids? no.7.Was there any physical harm to the customer as a result of the leak? no.

Manufacturer Narrative

Investigation summary: scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 system ivd, part # (b)(4) and serial # (b)(6).Problem statement: customer reported complaint on the spray of fluid under pressure, not contained within instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2020 to (b)(6) 2021.Complaint trend: there are 2 complaints related to the issue of spray fluid not contained within instrument under pressure; date range from (b)(6) 2020 to (b)(6) 2021.Manufacturing device history record (dhr) review: dhr part # (b)(4) 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 spray of fluid not contained within the instrument was due to a worn sheath fluid tube.The fse (field service engineer) found the source of the spray to be the sheath fluid line from a cut tubing.This cut tube seems to have been worn down due to constant chaffing against the metal casing of the wet cart.The fse replaced the tubing and ran cst and fluidic startup tests.No parts were requested for evaluation as tubing is not from stock inventory and the defective tubing was discarded.After the repair and testing, the instrument was working as intended and it was returned back to the customer.While there was a spray of fluid not contained within the instrument, it was not to a degree to significantly increase the risk of contact with the customer.Additionally, the fluid that leaked was sheath fluid and did not come in contact with the customer or bd personnel.Although patient samples were being used, the results captured were not used for any diagnosis due to the leakage so no patients were harmed.The safety risk is limited, s2, 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: (b)(6) 2008.Defective part number: n/a.Work order notes: o subject / reported: leaking unknown fluid from back of wetcart.O problem description: leaking unknown fluid from back of wetcart.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.Was there spray of fluid under pressure? yes.4.What was the fluid that leaked? unknown.5.What is the source of leak -- waste line or non-waste line? unknown.6.Was the customer exposed to blood or bodily fluids? no.7.Was there any physical harm to the customer as a result of the leak? no.O work performed: the sheath fluid tube had chaffed against the metal casing of the wet cart and was cut.Replaced the tubing with a non stock and test all okay.Run cst pass.Run multiple fluidic startups.All okay.Return machine back to customer in good working condition.Leaking sheath fluid from back of wetcart.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.Was there spray of fluid under pressure? yes.4.What was the fluid that leaked? sheath fluid.5.What is the source of leak -- waste line or non-waste line? cut in sheath tubing.6.Was the customer exposed to blood or bodily fluids? no.7.Was there any physical harm to the customer as a result of the leak? no.Cause: the sheath fluid tube had chaffed against the metal casing of the wet cart and was cut.Solution: replace tubing with non stock.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 # (b)(4), rev.01/vers.A, bd facscanto ii flow cytometer (fluidics) fmea was reviewed.No new hazards have been identified and the current mitigation is sufficient.The severity rating in this file is (b)(4) based on the previous scale rating.This rating is equivalent to (b)(4) in (b)(4) whereby the leakage was obvious or indicated by additional (warning) information and hence the impact to the customer is negligible to none.The current mitigations are adequate with rpn under acceptable range.Hazard(s) identified? yes ,no.O item: 4.Quick disconnect.O function: 4.1 connects tubing to filters and fluid tanks.O potential failure mode: 4.1.1 tubing failure.O potential effect(s) of failure: 4.1.1.1 leaks at waste tank.Biohazard.O potential cause(s)/mechanism(s) of failure: waste fitting leaks.O current controls: pump compensates for leaking.O recommended actions: n/a.O severity: 8.O occurrence: 4.O detection: 1.O rpn: 32.Mitigation(s) sufficient yes ,no.Root cause: based on the investigation results the root cause of the spray of fluid under pressure was due to a worn sheath fluid tube.Conclusion: based on the investigation results, the root cause of the spray of fluid under pressure was due to a worn sheath fluid tube.The fse found that the sheath fluid tubing had been cut from wear and tear, and replaced it.They then ran cst and multiple fluidic startups, and the instrument was working as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is limited, s2, and there was no impact to customer health or safety.

• Brand Name: BD FACSCANTO
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11332788
• MDR Text Key: 247033210
• Report Number: 2916837-2021-00050
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1