MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART; COUNTER, DIFFERENTIAL CELL

Catalog Number	338962
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	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd facscanto¿ ii system w/fluidics cart error message occurred, customer bypassed and continue testing.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that when run carousel it fails to pressurize 1st few samples, error message (#could not pressurize).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
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - (b)(6).H.6 investigation summary: based on the investigation results, the reported issue of experiencing failure to pressurize the 1st few samples and unable to run extended cleaning was confirmed.Investigation results that were performed on the indicated failure mode were the following: the complaint trend and service notes were reviewed.The potential cause for the customer experiencing failure to pressurize the 1st few samples and unable to run extended cleaning was due to a worn r2 sheath/sample regulator.The issue was resolved after the part was replaced.No further problems were noted and the instrument was confirmed to be functioning as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.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.
Event or Problem Description
It was reported that during use with bd facscanto¿ ii system w/fluidics cart error message occurred, customer bypassed and continue testing.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that when run carousel it fails to pressurize 1st few samples, error message (#could not pressurize).

• Brand Name: BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
• 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: 18017514
• Report Number: 2916837-2023-00208
• Device Sequence Number: 7604352
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 338962
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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