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	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D.4.Medical device expiration date: na h3 other text : see h10.
Event or Problem Description
It was reported that while using bd facscanto ii cytometer 4/2 system ivd failed to start up.There was no report of user impact.The following information was provided by the initial reporter: "this error happened on startup.Customer had completed a long clean on the instrument, but it still fails, wet cart pressure appears to be low.Requesting fse onsite to repair.Customer stated that she can hear an odd noise when starting the system and she is getting an e011 error." "mdr safety checklist - error messages (case): 1.Is this facspresto or facscount? if yes, no further questions required.If no, go to question #2.:no.2.Did the instrument display an error message? if yes, go to question #3.If no, no further questions required.:yes.3.Were patient samples run on the instrument after an error message was displayed? if yes, go to patient samples checklist.If no, no further questions required.:yes".
Additional Manufacturer Narrative
Investigation summary: based on the investigation results, the reported issue of obtaining an e011 error code and failing at startup 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 obtaining an e011 error code and failing at startup was due to a worn fluidic manifold in the wetcart.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 while using bd facscanto ii cytometer 4/2 system ivd failed to start up.There was no report of user impact.The following information was provided by the initial reporter: "this error happened on startup.Customer had completed a long clean on the instrument, but it still fails, wet cart pressure appears to be low.Requesting fse onsite to repair.Customer stated that she can hear an odd noise when starting the system and she is getting an e011 error." "mdr safety checklist - error messages (case) 1.Is this facspresto or facscount? if yes, no further questions required.If no, go to question #2.:no.2.Did the instrument display an error message? if yes, go to question #3.If no, no further questions required.:yes.3.Were patient samples run on the instrument after an error message was displayed? if yes, go to patient samples checklist.If no, no further questions required.:yes.".

• 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: 18421982
• Report Number: 2916837-2023-00234
• Device Sequence Number: 7965171
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: (01)00382903389605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/09/2024

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: 12/01/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2012
• 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