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

Catalog Number	338960
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error messages were bypassed and testing continued during use with the bd facscanto¿ ii flow cytometer.The following information was provided by the initial reporter: it was reported by the customer that error e009 - float switch timeout occurs when performing the long clean.The customer stated that she could bleed the bleach and water filters.She could not troubleshoot because she had a lot of samples to run.Email: customer is reporting an error e009 - float switch timeout when performing the long clean.Mdr safety checklist -- error messages.1.Are you running patient samples for diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required: yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required: yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required: yes.4.Is this presto? (either yes or no, no further questions required): no.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that error messages were bypassed and testing continued during use with the bd facscanto¿ ii flow cytometer.The following information was provided by the initial reporter: it was reported by the customer that error e009 - float switch timeout occurs when performing the long clean.The customer stated that she could bleed the bleach and water filters.She could not troubleshoot because she had a lot of samples to run.Email: customer is reporting an error e009 - float switch timeout when performing the long clean.Mdr safety checklist -- error messages.1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? ((if yes, go to question #4.If no, no further questions required.): yes.4.Is this presto? (either yes or no, no further questions required): no.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office contact - (b)(6).G.1 - manufacturing site contact - (b)(6).G.1 - reporting office- becton dickinson and company bd biosciences.H.3.Based on the investigation results, the reported issue e009 error - float switch timeout when performing the long clean was confirmed.Investigation results that were performed on the indicated failure mode were the following: manufacturing device history record (dhr) was reviewed and instrument met all the manufacturing specifications prior to release.The potential cause of the float switch timeout error was a bad filter.The field service representative (fsr) performed a service visit and found that the filter on the facsclean of the wet cart was not letting facsclean through the filter.They replaced the filter and purged the air out.After the works performed, the instrument was tested and meeting specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17906539
• Report Number: 2916837-2023-00192
• Device Sequence Number: 7645597
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Other
• Device Catalogue Number: 338960
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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