MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10

Model Number	647205
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd facs¿ sample prep assistant iii that cd45 counts are higher than the total cbc.The following information was provided by the initial reporter: cd45 counts are higher than the total cbc.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.
Event or Problem Description
It was reported that while using the bd facs¿ sample prep assistant iii that cd45 counts are higher than the total cbc.The following information was provided by the initial reporter: cd45 counts are higher than the total cbc.
Additional Manufacturer Narrative
H.6 investigation summary (b)(4); pn: 647205; spaiii; sn: (b)(6); awareness: 11/05/2022; opened: (b)(6) 2022.Investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: cd45 counts are higher than the total cbc.Manufacturing defect trend: there are (b)(4) qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months).Complaint trend: there is 1 complaint related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months) (b)(4) (this complaint).Investigation result / analysis: per fse¿s report: customer ran 2 full carousels of the same samples, 1 each on two different spa.Then customer ran those samples on the same canto.The spa in question showed a cd45 count of 4341 and a cbc count of 3271.The known good spa showed a cd45 count of 3463 and a cbc of 3271.Replaced sample rack and wash station pump.Tested and verified instrument performance.No further issues.There was no delay in patient treatment.Service max review: review of related work order#: wo (b)(4).Install date: (b)(6) 2010.Defective part number: 33429709 ¿ miniwash assembly / 33430109 ¿ mixer primary sample tube work order notes: subject / reported: cd45 counts are higher than the total cbc.Problem description: ineffective sample prep.Cause: electro-mechanical failure of the sample rack.Work performed: replaced sample rack mixer.Solution: replaced sample rack mixer.Parts replaced: 33430109-mixer primary sample tube.Returned sample analysis: the complaint sample was not requested to be returned and no photo(s) / picture(s) were provided.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes or no.Hazard id: 3.1.17.Hazard: ineffective sample prep.Cause: electro-mechanical failure of the sample rack motor.Harmful effects: improperly mixed primary tube.Residual severity: 3.Residual probability: (b)(4).Residual risk index: 3.Root cause: based on the investigation result and fse¿s report the root cause was by defective sample rack motor.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for cd45 counts are higher than the total cbc.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Common Device Name: SEE H.10
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15822700
• Report Number: 2916837-2022-00351
• Device Sequence Number: 12300876
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131301
• 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): 02/14/2023

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: 647205
• Device Catalogue Number: 647205
• 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: 11/05/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• 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