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

Model Number 338960

Device Problem Fail-Safe Problem (2936)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd facscanto¿ ii flow cytometer that there was an error message.The following information was provided by the initial reporter: they were receiving errors messages but that they were able to continue and run samples, run fluidic startup but starting today the errors became numerous : low blue laser power,low red laser power, fluidics board request shutdown , bish switch timeout and they were unable to get thru fluidics startup they were failing fluidics startup.I asked the customer to verify wetcart pressure and they stated that wetcart pressure was 35psi.I asked the customer to disconnect the air out line from the wetcart.The customer disconnected the line and the psi jumped to 70 psi.I then asked the customer to open the right panel of the cytometer and then reconnect the air line and when they did this the customer stated that they could hear some type of pressurizing air sound coming from the right side of the instrument.The customer did not feel comfortable preceding any further with troubleshooting so i will dispatch.Wecart pressure low 35psi.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 system ivd, part # 338960 and serial # (b)(6).Problem statement: the customer reported a complaint regarding low wet cart pressure error messages that occurred on 30jan2023.Error messages indicate the potential for the instrument generating erroneous results that can negatively impact patient diagnosis and treatment.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed by these erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue for part # 338960.Date range from 30jan2022 to date 30jan2023.Manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(6), file # (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.Manufacturing date: november 2011.Complaint trend: there are 20 complaints related to the issue of error messages caused by a pressure issue with a regulator (filtered using as reported code 1: ¿error message / code / alert / alarm¿, as analyzed code 1: ¿mechanical problem identified¿, as analyzed code 2: ¿pressure issue ¿ high / low / no¿, and as analyzed component: ¿regulator¿) for part # 338960; pr# 4548885, 4552809, 4768933, 4923438, 5594611, 5634489, 5717073, 6040143, 6066141, 6208767, 6239328, 6290886, 6340114, 6385139, 6486614, 6743981, 6810235, 7064950, 7074478, and this one, 7077031.Date range from 30jan2022 to date 30jan2023.Returned sample analysis: a return sample was not requested for evaluation because the replaced part is not returnable and was discarded.Service history review: review of related work order #: (b)(4); case #: (b)(4).Install date: 08dec2011.Defective part number: 343834 - sheath sample regulator assembly vert.Problem description: the customer reported receiving several error messages on the facscanto for low red & blue laser power, fluidics board request shutdown, bish switch timeout etc.While trying to run the fluidics startup.The customer contacted the technical service representative who told them to verify the wetcart pressure and disconnect and reconnect the air line, after which the customer requested support from the service team for low wetcart pressure (35 psi).Work performed / cause / solution: fse tested air pressure at various points in the instrument, and found and replaced a leaking sample pressure regulator.Fse tested and verified instrument.Risk review: risk management files part # 100264ra rev.06/vers.F ¿ canto plus risk analysis and part # 338942ra rev.09/vers.H ¿ facscanto product family risk analysis were reviewed.These files did not contain the relevant hazard(s) and mitigation(s), and an ecr has been opened to assess additional hazards and their risk levels.Ecr # (b)(4) has been created and will revise facscanto product family risk analysis (file # (b)(4), rev.09/vers.H) to include the cause, mitigation, and risk index for failures associated with the user bypassing error messages.Potential causes: based on the investigation results, the potential cause was determined to be a leaking sample pressure regulator.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, the potential cause was determined to be a leaking sample pressure regulator.A customer spoke with a tsr (technical service representative) about seeing various error messages regarding low laser power, fluidics board request shutdown, etc.That were preventing fluidic startup.Upon the tsr¿s request, the customer verified that the wet cart pressure was low (35 psi) and disconnected the air line from the wet cart to troubleshoot, but requested an fse (field service engineer) visit for further investigation.The fse found that the sample pressure regulator was leaking and replaced it, and also adjusted the wet cart pressure.They confirmed it was an air leak, so there was no risk of exposure to any fluid, biohazardous or otherwise.After the repair, the fse tested the instrument and confirmed that it was working as expected with no more error messages.No return sample was requested for evaluation because the replaced part is not returnable and was discarded.Although this issue could have impacted results from patient samples, the error messages prevented fluidic startup, so no erroneous results were produced.Therefore, no users or patients were harmed due to this issue.Regular maintenance is essential for keeping the instrument at its optimal performance.This information can be found in the bd facscanto¿ flow cytometer instructions for use (ifu) manual, #23-14730-03 rev.01/vers.A, starting on page 150.Troubleshooting procedures can be found in the ifu starting on page 184, and page 209 for data acquisition issues.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation results, the complaint was confirmed and the potential cause of the customer seeing error messages associated with low wet cart pressure was determined to be a leaking sample pressure regulator.The fse confirmed the issue and replaced the regulator.After the replacement, the instrument was tested and found to be functioning as expected.The error messages did not cause any erroneous results, so there was no impact to any patient diagnosis or treatment.The safety risk of this hazard has been identified to be within the acceptable level.Capa/sa determination: based on the investigation results, a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.Supporting document: n/a.

Event Description

It was reported that while using the bd facscanto¿ ii flow cytometer that there was an error message.The following information was provided by the initial reporter: they were receiving errors messages but that they were able to continue and run samples, run fluidic startup but starting today the errors became numerous : low blue laser power,low red laser power, fluidics board request shutdown , bish switch timeout and they were unable to get thru fluidics startup they were failing fluidics startup.I asked the customer to verify wetcart pressure and they stated that wetcart pressure was 35psi.I asked the customer to disconnect the air out line from the wetcart.The customer disconnected the line and the psi jumped to 70 psi.I then asked the customer to open the right panel of the cytometer and then reconnect the air line and when they did this the customer stated that they could hear some type of pressurizing air sound coming from the right side of the instrument.The customer did not feel comfortable preceding any further with troubleshooting so i will dispatch.Wecart pressure low 35psi.

• Brand Name: BD FACSCANTO¿ II FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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 ; 8448235433
• MDR Report Key: 16448528
• MDR Text Key: 310354246
• Report Number: 2916837-2023-00054
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1