MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that lwa¿s are not performing as they should and are resulting in a dramatic loss of sample post-wash.The following information was provided by the initial reporter: 2nd complaint made for k33714600276.From email 30/09/2022: we have also been able to demonstrate that the lwa¿s are not performing as they should and are resulting in a dramatic loss of sample post-wash.Alan has visited recently to try and rectify the issues with both lwa¿s but we have data to compare both manual washing and samples that have been washed on the lwa and the difference is stark ¿ to the point of affecting the final diagnosis.We have cases whereby a malignant clone has been washed away using the lwa and that would have led to a normal result being issued.Other samples are so limited that we would have reported them as being insufficient, despite the identification of a malignant population when washed manually.We have resorted to now washing all samples manually from today, but as you can imagine this will have significant impact on our processing times.

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that lwa¿s are not performing as they should and are resulting in a dramatic loss of sample post-wash.The following information was provided by the initial reporter: 2nd complaint made for (b)(6).From email 30/09/22: we have also been able to demonstrate that the lwa¿s are not performing as they should and are resulting in a dramatic loss of sample post-wash.Alan has visited recently to try and rectify the issues with both lwa¿s but we have data to compare both manual washing and samples that have been washed on the lwa and the difference is stark ¿ to the point of affecting the final diagnosis.We have cases whereby a malignant clone has been washed away using the lwa and that would have led to a normal result being issued.Other samples are so limited that we would have reported them as being insufficient, despite the identification of a malignant population when washed manually.We have resorted to now washing all samples manually from today, but as you can imagine this will have significant impact on our processing times.

Manufacturer Narrative

H.6 investigation summary scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146, and serial # (b)(6).Problem statement: customer reported a complaint regarding loss of sample post-wash causing erroneous results that occurred on (b)(6) 2022.Erroneous results can negatively impact patient diagnosis and treatment.The instrument underwent various repairs and was found to be functioning as expected, and neither the customer nor any patients were harmed by these erroneous results.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue for part # 337146.Date range from 04oct2021 to date 04oct2022.Manufacturing device history record (dhr) review: dhr part #337146 serial # (b)(6), file # (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 4 complaints related to the issue of erroneous diagnostic results for part # 337146; date range from 04oct2021 to date 04oct2022.Returned sample analysis: a return sample was not requested for evaluation because the replaced parts are not returnable and were discarded.Service history review: no case or work order was initiated in servicemax for this complaint.Review of related work order #: n/a; case #: n/a.Install date: 28may2012.Defective part number: n/a.Work order notes: n/a.Labeling / packaging review: n/a.Risk analysis: risk management file part # 337146ra, vers.B, bd facs¿ lyse/wash assistant risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes.No.Hazard id #: 3.1.4 hazard: 1.Un-prepped sample.2.No answer.3.Loss of sample.Cause: 1.Non recommended tube.2.Sensor window dirty.Harmful effects: 1.Delayed or no results.2.Increased cost of test due to need to re-prep then rerun.3.Blood exposure is higher risk without fixative.Residual probability: 1 residual severity: 3 residual risk index: 3 hazard id #: 3.1.5 hazard: loss of sample cause: 1.Bad connector.2.Overheated components.3.Insufficient electrical grounding.Harmful effects: delayed results.Residual probability: 1 residual severity: 3 residual risk index: 3 potential causes: based on the investigation, the potential causes were a failure of the screen and cable/wiring and a process issue.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, and risk analysis, the potential causes were a failure of the screen and cable/wiring and a process issue.In response to the customer reporting seeing unexpectedly low lymphocyte levels in b cell screens, an fse (field service engineer) went onsite to investigate the issue and replaced the screen on the lwa.However, the customer reported still having issues with low acquisition percents and high run times compared to manually processed samples.To investigate further, the customer ran comparison tests using different tubes since they had recently switched between conical/centrifuge tube brands and the lwa issues occurrence coincided with this change.The comparison tests showed that using the old tubes returned the acquisition to 100% and the run time decreased significantly.Lastly, to further improve the cell count issues, the fse replaced faulty cable/wiring.These repairs, in conjunction, helped to resolve the issue and the instrument was found to be functioning as expected.No parts were requested for evaluation as the replaced parts are not returnable and were discarded.Although this issue did produce erroneous results on patient samples, the customer confirmed that no erroneous results were reported to clinicians and no patients were diagnosed or treated using these results.No users or patients were harmed or injured due to these results.Troubleshooting procedures can be found in the user guide; bd facs¿ lyse wash assistant instructions for use, #23-11113 rev.02/vers.A, starting page 147.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 causes of the loss of sample post-wash causing erroneous results on lwa were determined to be a failure of the screen and cable/wiring and a process issue.To resolve the erroneous results issue, the fse replaced the screen and faulty cable/wiring on the lwa and the customer identified and fixed a process issue associated with the tubes used to run the samples.After these repairs, the acquisition returned to 100%, the runtime decreased significantly, and the instrument was found to be working to bd specifications.No one was harmed or injured, and no patients were diagnosed or treated based on any erroneous results.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.Supporting document:.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• 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: 15573402
• MDR Text Key: 307094546
• Report Number: 2916837-2022-00293
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 02/20/2023

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
• Device Operator: Other
• Device Model Number: 337146
• Device Catalogue Number: 337146
• Device Lot Number: K33714600276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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