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 09/15/2021

Event Type  malfunction  

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.

Event Description

It was reported that while testing patient sample on bd facscanto¿ ii flow cytometer erroneous results were obtained.There was no report of confirmatory testing.There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: facscanto ii ssc signal results are abnormal.Use of clinical samples ,does not affect patient treatment.Are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) - yes.Was there any delay of treatment due to the issue? (go to question #3)- no.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4)- no.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required)- no.

Event Description

It was reported that while testing patient sample on bd facscanto¿ ii flow cytometer erroneous results were obtained.There was no report of confirmatory testing.There was no patient impact.The following information was provided by the initial reporter, translated from chinese to english: facscanto ii ssc signal results are abnormal.Use of clinical samples ,does not affect patient treatment.1.Are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) - yes.2.Was there any delay of treatment due to the issue? (go to question #3)- no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4)- no.4.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required)- no.

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 results with the ssc signal being abnormal.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 15sep2020 to date 15sep2021.Complaint trend: there are 22complaints similar and related to this issue of abnormal ssc signal, including this one.Date range from 15sep2020 to date 15sep2021.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 customer obtaining issues with the ssc signal was due to a dirty fluidics system.A dirty fluidics can contribute to unexpected or erroneous results.The fse (field service engineer) confirmed the issues and replaced the valve group, optical fiber and flow chamber of the instrument.He also performed a pm (preventative maintenance) and adjusted the fluid pressure to 3.8 psi.No return samples were requested for evaluation because the replaced parts are not returnable and were discarded.After the repair and adjustments, the instrument was operating 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.No patient was harmed or injured due to the unexpected results.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, starting on page 150.Troubleshooting procedures can be found in the ifu starting on page 181, and page 201 for data issues.The safety risk is limited, s2, and there was no impact to patient health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: 26mar2014.Defective part number: n/a.Work order notes: o subject / reported: pi-338960-facscanto ii-ssc signal result is abnormal.O problem description: facscanto ii ssc signal results are abnormal.Use of clinical samples does not affect patient treatment.Inside the guarantee, i hope to come home as soon as possible.O work performed: replace the pmkit, measure the fiber outlet power of the 488nm laser to be 8.8mw, and adjust the sheath fluid pressure to 3.8psi.Pass the cst calibration.The valve group, optical fiber and flow chamber of the instrument need to be replaced later.The test result of the test sample is normal.O cause: the signal obtained after loading the sample is abnormal, and it stabilizes after drifting from the normal position to the lower left.O solution: replace the pmkit, measure the fiber outlet power of the 488nm laser to be 8.8mw, and adjust the sheath fluid pressure to 3.8psi.Pass the cst calibration.The valve group, optical fiber and flow chamber of the instrument need to be replaced later.The test result of the test sample is normal.Returned sample evaluation: a return sample was not requested because the replaced parts were not returnable and were discarded.Risk analysis: risk management file part #338960-04ra, version a, bd facscanto ii flow cytometer (fluidics) fmea was reviewed.The higher severity rating in this file is a ¿9¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, whereby the unexpected result is obvious or indicated by additional (warning) information and hence the impact to the patient is negligible to none.The current mitigations are adequate with rpn under acceptable range.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes or no? o item: 7.1/8" - 1/16" fluidics coupling.O function: 7.1 connect 1/8" id trap tubing to 1/16" pinch valve tubing.O potential failure mode: 7.1.1 clogs with salt crystals.O potential effects of failure: 7.1.1.1 biohazard exposure.O potential causes/mechanisms of failure: 7.1.1.1.1 waste trap overflows, leaks through bypass (biohazard).O current controls: automatic shutdown of fluidics, with di rinse.O recommended actions: 1.Eliminate reducer.2.Incorporate level sensor in waste buffer tank.3.Increase di cycle rinse time.O responsible party: 1,3.(b)(6).2.(b)(6).O target completion date: n/a.O actions taken: 1.Nexus change sheet nx-1088.2.Nexus change sheet nxb-2127 (complete 7/18/05).3.Clearcase entry 11/21/03 ((b)(6)).O sev: 9.O occ: 2.O det: 5.O rpn: 90.O item: 9.Check valve #17.O function: 9.1 prevent backflow of contaminants into sample.O potential failure mode: 9.1.1 sample "mushroom" forms in flow cell.O potential effects of failure: 9.1.1.1 noise, wrong results, unwanted events in gate.O potential causes/mechanisms of failure: 9.1.1.1.1 tube not removed, causing backpressure.O current controls: user examines dot plots.O recommended actions: leave fluidics running at low flow rate.O responsible party: (b)(6).O target completion date: n/a.O actions taken: n/a.O sev: 5.O occ: 7.O det: 2.O rpn: 70.Mitigation(s) sufficient: yes or no? root cause: based on the investigation results the root cause of the erroneous results was due to a dirty fluidics system.Conclusion: based on the investigation results, the root cause of erroneous results within the facscanto instrument was due to dirty fluidics system.This was confirmed by the fse who replaced parts and performed a pm.After the repairs and adjustments, the instrument was functioning as expected.No treatment or diagnosis was given due to the unexpected results.The safety risk is limited, s2, and there was no impact to patient health or safety.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12599024
• MDR Text Key: 276180893
• Report Number: 2916837-2021-00391
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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
• 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: 09/15/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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