MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿; FLOW CYTOMETRIC REAGENTS AND ACCESS

Model Number	662878
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	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd facslyric¿ that there was carryover involving patient samples.The following information was provided by the initial reporter: mdr safety checklist -- patient samples 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): no carry over of samples.
Additional Manufacturer Narrative
G.5 pma / 510(k)#: k170974, k201814.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 facslyric¿ that there was carryover involving patient samples.The following information was provided by the initial reporter: mdr safety checklist -- patient samples.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): no carry over of samples.
Additional Manufacturer Narrative
Scope of issue: the scope of issue is limited to facslyric 3l10c instrument us, part # 662878, serial # (b)(6).Problem statement: customer reported a complaint regarding carryover of samples that occurred on (b)(6) 2023.Carryover poses the risk of producing erroneous results that might impact patient diagnosis and treatment.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 0 qns (quality notifications) related to the reported issue for part # 662878.Date range from 02jun2022 to date 02jun2023.Manufacturing device history record (dhr) review: dhr part # 662878, serial # (b)(6) , file # 662878-662878-z662878000009-105529340-17 was reviewed.The instrument met all the manufacturing specifications prior to release.Instrument date of manufacture: 19oct2017.Complaint history review: there are 3 complaints related to the issue of carryover (filtered using as reported code 1: ¿contamination ¿ carry over¿) for part # 662878; pr # (b)(4).Date range from 02jun2022 to date 02jun2023.Returned sample analysis: a return sample was not requested for evaluation because the replaced part is not returnable and was discarded.Service history review: review of related work order #: (b)(4) , 03022197; case #: (b)(4).Install date: 13nov2017.Defective part number(s): 647939 - p2 aspirator pump (b)(4) notes: carryover of samples reported and sit flush may not be functioning properly.After replacing the pinch valve and its tubing and the p2 pump, they determined the root cause was the pump not working correctly.The instrument then tested without errors and was released to the customer for normal use.Risk analysis: risk management file part # 10000063058ra, rev.08/vers.Ab, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes,no? hazard id #: libivd-ra-100 3.1.7.Hazard: incorrect output for samples up to 1.5ml or less.Cause: sample carryover error - fluidic.Harmful effects: events appear in wrong tube (false positive result).Residual probability: 1.Residual severity: 3.Residual risk index: 3.Potential causes: based on the investigation results, the potential cause was determined to be a faulty p2 pump.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax review, the potential cause was determined to be a faulty p2 pump.In response to the customer reporting carryover of samples, an fse (field service engineer) went onsite and confirmed the issue.The fse replaced the v8 pinch valve and its tubing as well as the p2 pump (part # 647939 ¿ p2 aspirator pump), and determined that the latter was not functioning properly.After the repairs, the instrument was retested and found to be functioning per bd specifications without any further carryover and was returned to the customer for use without restrictions.Though this instrument is used to run patient diagnostic tests, the carryover did not cause erroneous results on patient samples.The customer immediately stopped using the instrument once they identified the carryover issue to avoid impacting patient samples.Therefore, no results were reported to clinicians or used to diagnose or treat any patients.No one was harmed or injured due to this issue.Proper daily and monthly cleaning procedures to help with troubleshooting can also be found under ¿maintenance¿ in the user guide; bd facslyric¿ clinical system instructions for use, #23-19938-04 rev.01/vers.A, page 170.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation results, the complaint was confirmed and the potential cause of the customer seeing sample carryover was determined to be a faulty p2 pump.The fse confirmed the issue and replaced the pump (part # 647939) as well as valve v8 and its tubing.After the repair, the instrument was tested and found to be functioning as expected with no further carryover.No one was harmed or injured, and there were no erroneous results on patient samples.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.H3 other text : see h10.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• 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: 17139721
• Report Number: 2916837-2023-00122
• Device Sequence Number: 3930977
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: 00382906628787
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K170974
• 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): 12/29/2023

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: 662878
• Device Catalogue Number: 662878
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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