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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

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.(b)(4).

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer erroneous results occurred on patient samples.There was no report if repeat or confirmatory testing was performed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the instrument is experiencing qc and sample issues.Are you using this for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury, or potential injury? no.Software version? unknown.Leak (if yes explain)? no.Additionally, on 2020-10-22, the fse provided the following additional information: are there erroneous results on patient samples from diagnostic test? yes.Was there any delay in treatment due to the issue? unknown.If patient samples were redrawn, was there any change or delay in of treatment? not applicable.Was there physical harm/injury to the patient due to this issue? no."the results were erroneous yes (as indicated in the in the questionnaire), but the results were not reported for treatment, as indicated in the template." "the qc was not bypassed, it failed due to a dirty flow cell.Once the flow cell was cleaned the qc's passed with no issues.".

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 complaint on a cst failing performance check.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from (b)(6) 2019 to date (b)(6) 2020.Complaint trend: there are no other complaints aside from this one, pr# (b)(4), related to cst failing performance check and qc and sample issues.Date range from (b)(6) 2019 to date (b)(6) 2020.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 failing cst tests and unexpected results was a dirty flow cell.Clogs and any dirt or debris on the flow cell can contribute to inaccurate readings or unexpected results on various tests.Prior to the field service the customer was instructed to perform a long clean, though the issue persisted despite that action and an fse was dispatched.The fse found that the cst tests were failing due to the flow cells and were not bypassing the qc and cleaned the flow cell with contrad (lab detergent).They then verified signals and qcs which were in spec.After the cleaning cst and 7 colors tests were run and were both in spec.No parts were requested for evaluation since nothing had to be replaced, only cleaned.After the repair the instrument was tested and was performing as expected.This error did result in erroneous results on patient samples, but they were not used to treat a patient and so no patient was harmed from these incorrect results.Refer to user guide bd facscanto ii flow cytometer instructions for use, document #23-20269-00, chapter 10 maintenance for instructions on how to perform a deep clean and instructions on how to properly clean the flow cell.After the repair, the instrument was rebooted, tested and functioning as expected.The safety risk is low, 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: (b)(6) 2009 defective part number: n/a work order notes: subject / reported: qc and sample issues problem description: having caller do a long clean.She will call us back to let us know.Work performed: verified all signals.Cleaned with contrad.Repair/troubleshooting performed: cleaned flow cell with contrad.Removed flow cell to clean external.Aligned optics.Verified all signals.The customer verified qc¿s, all in spec.Completed cst¿s and 7 color.Verified laser power, all in spec.Calibrated equipment serial numbers/expiration dates used (if applicable): power max pc.Software version: 8.0.1 cause: dirty flow cell solution: issue resolved (y/n) y.If unresolved, what are the next steps? : na.Instrument operating as intended (y/n)? (if applicable): y returned sample evaluation: a return sample was not requested because there were no parts that needed to be replaced.Risk analysis: risk management file part # 338960-03ra, rev.02/vers.A, risk analysis canto ii optics was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes no.Item: 6.Fsc detector o function: 6.1 detect forward scatter - future apps o potential failure mode: 6.1.1 excess noise o potential effect(s) of failure: 6.1.1.1 cells not identified o potential cause(s)/ mechanism(s) of failure: 6.1.1.1.1 dirty flow cell o current controls: long clean (monthly) and preventive maintenance (6 months).Daily qc using set-up beads.O probability: 2 o severity: 2 o risk index: 4 mitigation(s) sufficient yes.No.Root cause: based on the investigation results the root cause of failing cst tests was a dirty flow cell.Conclusion: based on the investigation results, the root cause of the failing cst test was a dirty flow cell.The fse cleaned the flow cell and realigned the optics before confirming the signals and qcs.They then completed the cst and 7 color and verified the lasers were in spec.After the cleaning the instrument was working as intended, though the fse recommended to the customer to complete a long clean.No one was harmed or injured as a result of this issue and no medical diagnosis was performed due to the erroneous results.The safety risk is low, s2, and there was no impact to patient health or safety.

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer erroneous results occurred on patient samples.There was no report if repeat or confirmatory testing was performed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the instrument is experiencing qc and sample issues.Are you using this for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Software version? unknown.Leak (if yes explain)? no.Additionally, on 2020-10-22 the fse provided the following additional information: are there erroneous results on patient samples from diagnostic test? yes.Was there any delay in treatment due to the issue? unknown.If patient samples were redrawn, was there any change or delay in of treatment? not applicable.Was there physical harm/injury to the patient due to this issue? no."the results were erroneous yes (as indicated in the in the questionnaire), but the results were not reported for treatment, as indicated in the template." "the qc was not bypassed, it failed due to a dirty flow cell.Once the flow cell was cleaned the qc's passed with no issues.".

• 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
• MDR Report Key: 10793991
• MDR Text Key: 215076679
• Report Number: 2916837-2020-00229
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1