MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿

Catalog Number 663029

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd facslyric¿ that there were carryover issues, erroneous results, and a leak.The following information was provided by the initial reporter: customer operation is currently impacted, with >50% instrument capacity loss.They are now checking for work-arounds to add additional washing tubes between samples to eliminate carry-over.The customer reports that they detected sample carryover.(b)(6) 2022: mdr laser safety evaluation checklist.Mdr safety checklist - leak.Mdr safety checklist - patient samples.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6: investigation summary: scope of issue: the scope of issue is only limited to facslyric 3l12c instrument ceivd, part # 663029, and serial # (b)(6).Problem statement: the customer reported a complaint regarding an issue with the sample carryover on 15nov2022.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue with part # 663029.Date range from 15nov2021 to date 15nov2022.Device history record (dhr) review: dhr part # 663029 serial # (b)(6), file # (b)(4) was reviewed.The instrument manufacturing date is 22mar2021 and instrument met all the manufacturing specifications prior to release.Complaint history review: there are 7 complaints related to the issue of carry or contamination for part # 663029.Pr# (b)(4).Date range from 15nov2021 to date 15nov2022.Returned sample analysis: a complaint sample was not requested to be returned because no parts were replaced.Service history review: review of related work order #: (b)(4); case # (b)(4).Install date: 27apr2021.Defective part number: n/a.Work order notes: subject / reported: (b)(4) - facslyric - sample carryover.Problem description: the customer reports that they detected sample carryover.Work performed: checked instrument on arrival.Sit needle was dripping when executing a sit flush.In the fluidics bucket found that the waste tube to evacuate the cleaning droplets was blocked.Unblocked tubing and now sit does not drip.Overall check-up of sit flush mechanics.No more issues found.Customer ran new carry-over check and passed.For this instrument seems like the blocked tubing was the root cause.Final checklist of items verified during intervention : 1) sit need droplets : 2 - 3 drops.2) sit needle height : aligned properly with bd tool.3) sit needle vacuum tube ok, not pinched.Wh 21 nov : sit flush validation conform bd procedure flyr-22-38 + replacement of a written-off flowcell blue restrictor.No technical deviation was found and instrument meets technical specifications.Customer will validate if the instrument still has carry-over and inform us asap.Wh 6dec : after previous technical validations, it appears that the carry-over is purely an application topic.Carry-over can only be measured according to a specific nen-norm.Application ( dennis tielemans ) will go onsite to discuss with customer.The conclusion is that the customer was not measuring carry- over according to the norm : clinical and laboratory standards institute h62 protocol, validation of assays performed by flow cytometry.Summary: the fse unblocked the waste tubing line and now sit does not drip.It was most likely the blocked tubing that was the root cause because the droplets were not being aspirated.Instrument is running as expected after the repair.Parts replaced: n/a.Labeling / packaging review: n/a.Risk analysis: risk management file part # (b)(4), rev.08/vers.Ab, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes ,no.Azure id: (b)(4).Id: (b)(4).Reg status: ivd; ruo.Hazard: exposure to biological sample.Cause: back drip from injection port.Harmful effects: wrong results by cross contamination.Residual probability: 1.Residual severity: 3.Residual risk index: 3.Residual risk evaluation: a.New hazards: none.Potential causes: based on the investigation, the potential cause of carryover is due to a blocked waste tubing.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, the potential cause of carryover was due to a blocked waste line tubing preventing the pump to aspirate the droplets on the sit.This was confirmed by the fse (field service engineer) after unclogging the line and the instrument was performing as expected, with no adverse leaking from the sit.No part was requested for evaluation as the parts that were replaced were not returnable, therefore was discarded.Although this complaint involves erroneous results, no results were reported to the clinician, nor was a patient harmed or injured from diagnosis.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation, the complaint was confirmed and the potential cause of carryover was due to a blocked waste line tubing.An fse helped resolve the issue and the instrument was performing as expected with no further leaks from the sit.No erroneous results were reported to clinicians and no patients were harmed due to this issue.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 there was no impact to customer and patient health or safety.Supporting document: n/a.

Event Description

It was reported that while using the bd facslyric¿ that there were carryover issues, erroneous results, and a leak.The following information was provided by the initial reporter: customer operation is currently impacted, with >50% instrument capacity loss.They are now checking for work-arounds to add additional washing tubes between samples to eliminate carry-over.The customer reports that they detected sample carryover.18th nov 2022: mdr laser safety evaluation checklist.Mdr safety checklist - leak.Mdr safety checklist - patient samples.

• Brand Name: BD FACSLYRIC¿
• Type of Device: NA
• 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: 15964845
• MDR Text Key: 305665074
• Report Number: 2916837-2022-00364
• Device Sequence Number: 1
• Product Code: OYE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K201814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 663029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1