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

Model Number	338962
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4 initial reporter phone # (b)(6).D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd facscanto¿ ii flow cytometer that there was carryover involving patient samples.The following information was provided by the initial reporter: hazard, injury or erroneous results? no hazard, injury or erroneous results details cst fails with cannot place beads on scale with maximum pmtv, threshold set to fitc - seen on histogram population, on apc - seen on histogram population, asked to restart the customer reported that population on fsc/ssc is pushed against axis.
Event or Problem Description
It was reported that while using the bd facscanto¿ ii flow cytometer that there were erroneous results on patient samples.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples for diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.The customer reported that population on fsc/ssc is pushed against axis.
Additional Manufacturer Narrative
H.6: scope of issue: the scope of issue is only limited to bd facscanto ii fl cytometer ivd 4/2/2 sys rec part # 33896209 and serial # (b)(6).Problem statement: customer reported complaint regarding fsc/ssc pressed against axis on (b)(6) 2023.Erroneous results pose the risk of harming or injuring the patient due to misdiagnosis.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2022 to (b)(6) 2023 device history record (dhr) review: dhr part # 33896209 serial # (b)(6) file # 338963- v96300055-900076989-06 was reviewed.The instrument met all the manufacturing specifications prior to release.Date of mfg.Jul2006.Complaint history review: there is 1 complaint related to as reported code 1 results erroneous diagnostic.This (b)(4).Date range (b)(6) 2022 to (b)(6) 2023.Returned sample analysis: a return sample was not requested because no parts were replaced.Service history review: review of related work order # (b)(4).Install date: 07jul2021.Work order notes: cause: dirt in the flow cell.Solution: fse checked fsc and ssc values.Fse also rinsed and cleaned flow cell after which a cs&t performance check was performed and the instrument is functioning as expected.Risk analysis: risk management file part # 338960-04ra, rev.01/vers.A, 338960-04ra, risk analysis canto ii fluidics was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes/no.Item (hazard id) :25 flow cell: potential failure mode (hazard): 22.5.1 sample enters sheath stream.Potential cause(s)/ mechanism(s) of failure (cause): 22.5.1.1.1 software.Crashes, stopping sheath flow within flow cell, trapping sample inside flow cell.Enters v.Sheath stream on next use.Potential effect(s) of failure ( harmful effects): 22.5.1.1 performance compromised.Residual sev:5.Residual occ :1.Residual det: 5.Residual rpn : 25.Potential causes: based on the investigation results, the potential cause was determined to be a dirty flow cell.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause of erroneous results was determined to be a dirty flow cell.The customer reported a complaint regarding fsc/ssc pressed against axis.This issue was confirmed by the field service representative (fsr) who checked fsc and ssc values and rinsed and cleaned flow cell with facsclean.Afterwards, the instrument is functioning as intended.Erroneous results were not reported to the clinicians and no patient was diagnosed or treated based on any erroneous 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.Conclusion: based on the investigation results, complaint was confirmed and the potential cause was determined to be a dirty flow cell.The customer reported a complaint regarding fsc/ssc pressed against axis.The issue was confirmed by the field service representative (fsr) who cleaned and rinsed the flow cell.This resolved the issue.Afterwards, the instrument was functioning as intended.No one was harmed or injured, and no patients were harmed from any erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.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.
Event or Problem Description
It was reported that while using the bd facscanto¿ ii flow cytometer that there were erroneous results on patient samples.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples for diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.The customer reported that population on fsc/ssc is pushed against axis.
Additional Manufacturer Narrative
The following fields have been updated with corrected information- b.5- description of event or problem has been modifies from: it was reported that while using the bd facscanto¿ ii flow cytometer that there was carryover involving patient samples.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.Cst fails with cannot place beads on scale with maximum pmtv, threshold set to fitc - seen on histogram population, on apc - seen on histogram population, asked to restart.The customer reported that population on fsc/ssc is pushed against axis.Corrected to: it was reported that while using the bd facscanto¿ ii flow cytometer that there were erroneous results on patient samples.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples for diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.The customer reported that population on fsc/ssc is pushed against axis.
Additional Manufacturer Narrative
The following fields have been updated with corrected information- date received by manufacturer 08/15/2023 has been corrected to: 05/24/2023 b.5- description of event or problem has been modified from: it was reported that while using the bd facscanto¿ ii flow cytometer that there was carryover involving patient samples.The following information was provided by the initial reporter: hazard, injury or erroneous results? no hazard, injury or erroneous results details cst fails with cannot place beads on scale with maximum pmtv, threshold set to fitc - seen on histogram population, on apc - seen on histogram population, asked to restart the customer reported that population on fsc/ssc is pushed against axis corrected to: it was reported that while using the bd facscanto¿ ii flow cytometer that there were erroneous results on patient samples.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples for diagnostic test? yes 2.Was there any delay of treatment due to the issue? no the customer reported that population on fsc/ssc is pushed against axis.
Event or Problem Description
It was reported that while using the bd facscanto¿ ii flow cytometer that there were erroneous results on patient samples.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples for diagnostic test? yes 2.Was there any delay of treatment due to the issue? no the customer reported that population on fsc/ssc is pushed against axis.

• Brand Name: BD FACSCANTO¿ II FLOW CYTOMETER
• Common Device Name: 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17172050
• Report Number: 2916837-2023-00126
• Device Sequence Number: 15242254
• Product Code: GKZ
• UDI-Device Identifier: 00382903389629
• UDI-Public: 00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2023

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
• Operator of Device: Other
• Device Model Number: 338962
• Device Catalogue Number: 33896209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 05/24/2023; 12/11/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/17/2023; 08/18/2023; 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown