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

Model Number 338960

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd facscanto¿ ii flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: "are there erroneous results on patient samples from diagnostic test? yes.Were the samples analyzed on the instrument patient samples? no.If they were patient samples, were incorrect results obtained or used? no.Any treatment provide to the patient based on the result? no.Was there any harm to the patient? no.Ssc signal results are abnormal.Use of clinical samples does not affect patient treatment.".

Manufacturer Narrative

H6: 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: customer reported a complaint regarding the instrument producing erroneous result.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 22dec2020 to date 22dec2021.¿ complaint trend: there are 17 complaints related to the issue of erroneous results.These complaints can be found in the attached complaint trend file.Date range from 22dec2020 to date 22dec2021.¿ 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.¿ 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 erroneous results from the optical path failure was due to a worn flowcell and blue optical fiber.The customer had initially reported that the ssc signals were abnormal and an fse (field service engineer) was sent onsite to observe the issue.This repair was split up between two complaints per (b)(4) ¿ wfi ¿ clarify.(b)(4) covers the repairs for the fluid flow failure, and this complaint, (b)(4), covers the repairs for the optical path failure.In order to repair the optical path failure, the fse replaced the 488nm blue optical fiber (pn 335384) and flowcell (pn 64003107).Although the blue optical fiber and flowcell are returnable, the customer reported that the return sample was not able to be sent back.After all the repairs, the instrument was tested and functioning as expected.Although the instrument was used for diagnostic testing the issue was identified and resolved before the patient sample results were used for any diagnosis or treatment.Cleaning the fluidics and regular maintenance is essential for keeping the instrument at its optimal performance.This information can be found in the bd facscanto¿ ii flow cytometer instructions for use (ifu) manual, #23-20269-00 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) 2014.Defective part number: 64003107 - assembly flowcell facs canto ii service.335384 - kineflex blue laser fiber.Work order notes: o subject / reported: pi-338960-facscanto ii-ssc signal results abnormal.O problem description: abnormal facscanto ii ssc signal results the use of clinical samples did not affect the patient's treatment if the failure occurs again, i hope the engineer will come to the door as soon as possible, and the guarantee is guaranteed.O work performed: replace one set of flow chamber, one set of valve group, 488nm blue optical fiber, waste buffer bottle, loader drawer bayonet, set the sheath fluid pressure to 3.6psi, check the signal, correct the optical path, adjust the drawer position, and pass the cst calibration.O cause: the ssc signal obtained by loading the sample is abnormal.After about 10 seconds, it drifts from the normal position to the bottom and stabilizes.O solution: replace one set of flow chamber, one set of valve group, 488nm blue optical fiber, waste buffer bottle, loader drawer bayonet, set the sheath fluid pressure to 3.6psi, check the signal, correct the optical path, adjust the drawer position, and pass the cst calibration.¿ returned sample evaluation: although the flowcell and blue laser fiber are returnable, the parts were unable to be sent back for evaluation.¿ risk analysis: a review of the bd facscanto ii flow cytometer (daq) fmea #338960-05ra (version a/revision 1) has identified the cause of a faulty optical fiber in item ¿5.Optical fiber¿.A review of the bd facscanto ii flow cytometer (fluidics) fmea #338960-04ra (version a/revision 1) has identified the cause of a dirty flowell in item ¿22.Flowcell¿.These risks contains the appropriate mitigations and have safety risks within acceptable levels.Hazard(s) identified? yes no.O item: 5.Optical fiber.O function: 5.1 maintains laser polarization.O potential failure mode: 5.1.1 reduced laser power.O potential effects of failure: 5.1.1.2 cvs out of spec.O potential causes/mechanisms of failure: 5.1.1.1.2 low or varying power due to misalignment.O current controls: setup voltages change.O recommended actions: n/a.O responsible party: n/a.O target completion date: n/a.O actions taken: n/a.O sev: 4.O occ: 4.O det: 4.O rpn: 64.O item: 22.Flow cell.O function: 22.4 remain optically clean.O potential failure mode: 22.4.1 optical clarity degraded.O potential effects of failure: 22.4.1.1 signal degradation or loss - misclassification.O potential causes/mechanisms of failure: 22.4.1.1.1 residue accumulation on walls or optical gel degradation (discoloration).O current controls: sensitivity test (fails when sensitivity drops too low).O recommended actions: 1.Implement p-trap and lower waste trap, to prevent.Siphoning of fluids out of flow cell.2.Instructions for use: recommend to shut down cytometer nightly, perform fluidics shutdown.Software shall remind user to shutdown before quitting application.3.Fse instructions for annual cleaning cuvette.O responsible party: 1) (b)(6).2) (b)(6).3) (b)(6).O target completion date: (b)(6) 2006.O actions taken: 1.Waste trap lowered and p-trap tubing implemented, to prevent siphoning in either direction (canto b change sheet nxb-2028).2.Bd facscanto ii ifu (640773) - chapter 9.3.Revise service procedures to include recommendation for annual flow cell recoupling and cleaning.Refer chapter 4 in bd facscanto ii service manual (640597) o sev: 8; o occ: 1; o det: 9; o rpn: 72.Mitigation(s) sufficient yes no.Root cause: based on the investigation results, the root cause of the erroneous results from the optical path failure was due to a worn flowcell and optical fiber.Conclusion: based on the investigation results, the root cause of the erroneous results from the optical path failure was due to a worn flowcell and optical fiber.This complaint has been split up between (b)(4) regarding a fluid flow failure and this one, (b)(4), regarding the optical path failure.In order to resolve this issue, the fse replaced the 488nm blue optical fiber (pn 335384) and flowcell (pn 64003107).After all the repairs the instrument was tested and functioning as expected.No treatment or diagnosis was given due to the unexpected results.The safety risk of this hazard has been identified to be within the acceptable level.

Event Description

It was reported that bd facscanto¿ ii flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: "are there erroneous results on patient samples from diagnostic test? yes were the samples analyzed on the instrument patient samples? no if they were patient samples, were incorrect results obtained or used? no any treatment provide to the patient based on the result? no was there any harm to the patient? no ssc signal results are abnormal.Use of clinical samples does not affect patient treatment".

• 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 ; 8015296192
• MDR Report Key: 13089731
• MDR Text Key: 284385777
• Report Number: 2916837-2021-00499
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• 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