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 10/31/2022

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.Initial reporter addr 1: (b)(6).Reporter e-mail: (b)(6).

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that there were cell that were lost in the washers.The following information was provided by the initial reporter: loss of cells was observed in tubes processed in washers (around 50%).

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: the customer reported a complaint regarding observed cell loss between samples on (b)(6) 2022.Cell loss can lead to erroneous results being used for patient diagnosis and subsequent misdiagnosis, but these results were immediately identified, and the patient was not harmed in any way.The instrument is currently functioning as expected.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from (b)(6) 2021 to date (b)(6) 2022.Manufacturing device history record (dhr) review: dhr part #337146, serial # (b)(6), file #337146-337146-r337146000815-105734715-18, was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 5 complaints regarding the instrument producing erroneous results for this part number within the date range;.Date range from (b)(6)2021 to date (b)(6)2022.Returned sample analysis: a return sample was not requested because there were no replaced parts.Service history review: review of related work order #: (b)(4), case # (b)(4).Install date: 16jul2018 defective part number: n/a work order notes: n/a subject: cell loss description: loss of cells was observed in the tubes processed in the washers (around 50%).Work performed: the purpose of the visit was to evaluate the performance of the sector's lwas, after reporting a significant loss of cells in the processed samples.Below are the steps of the investigation: 1- discussion with the team to understand the workflow with the routine assistant equipment (lwas): a.We identified that sample processing starts on the bench, and the sample washing process takes place in the lwa; b.We identified that the sector used a volume of lysis solution for sample processing higher than that recommended by the bd: about 2ml added lysis, sample and antibody; ç.Bd recommends using a maximum of 1065ul of lysis solution + sample and antibody in lwa; 2- cause of the problem: the.With this information collected and analysis of the cases, we identified that the cell loss (50%) was due to the extravasation of the excess volume of lysis solution used in the sample preparation process.3- initial actions and conclusions: a.Discussion and instruction of the team regarding recommended maximum volumes of solution for lwa protocols.B.Initial tests to assess solution volume reduction and lysis efficiency versus cell concentration maintenance.Ç.Analysis of the initial tests showed that reducing the volume of lysis solution with an increase in the incubation time were efficient for lysing the samples and maintaining the desired cell concentration.D.New protocol designed in the lwa so that the processing (lysis and washing) of the samples is carried out in the equipment.And.Equipment released for routine.4- next steps: a.Lwa retraining for the team (to be defined) b.Tests to evaluate the efficiency of cell lysis using different types of samples with different collection times, focused on maintaining the initial cell concentration.Work performed: with this information collected and analysis of the cases, we identified that the cell loss (50%) was due to the extravasation of the excess volume of lysis solution used in the sample preparation process.Cause: with this information collected and analysis of the cases, we identified that the cell loss (50%) was due to the extravasation of the excess volume of lysis solution used in the sample preparation process.Solution: initial actions and conclusions: a.Discussion and instruction of the team regarding recommended maximum volumes of solution for lwa protocols.B.Initial tests to assess solution volume reduction and lysis efficiency versus cell concentration maintenance.Ç.Analysis of the initial tests showed that reducing the volume of lysis solution with an increase in the incubation time were efficient for lysing the samples and maintaining the desired cell concentration.D.New protocol designed in the lwa so that the processing (lysis and washing) of the samples is carried out in the equipment.And.Equipment released for routine.The following participated in the initial discussions and investigation of the problem: ana claudia, mariana.Alignment with the sector team, alessandra and yumi.Labeling / packaging review: n/a risk analysis: risk management file part # 10000597659, rev.03/vers.C, 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 #: 3.1.8 hazard: too much lysing solution dispensed cause: compromised integrity of cells harmful effects: improperly prepared samples that leads to inaccurate results, loss of samples residual probability: 1 residual severity: 3 residual risk index: 3 potential causes: based on the investigation, a potential cause of the erroneous results was an incorrect volume of solution being used during instrument operation.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, it was determined that a potential cause of the erroneous results was an incorrect volume of solution being used during instrument operation.The customer had initially reported that they observed cell loss when running the samples.Several representatives from bd went out on the field to investigate the reported issue and go over the customer¿s internal protocol.The team had a discussion with the customer and were able to identify that the customer was using a larger volume of solution than was recommended by bd.After analyzing the results of several tests performed on the instrument, it was demonstrated that a reduction of solution and increase in incubation time sufficiently prepared the samples.After a review and improvement of the customer¿s lwa operation protocol as well as customer training, no further issues were reported.No parts were requested for evaluation as there were no parts replaced.Although the erroneous results occurred while using patient samples, the customer confirmed that the erroneous results were not used and no patients were harmed.Additionally, the erroneous results did not cause a delay in the treatment of any patients.The results were captured prior to any diagnosis decision and was reported to bd as not expected.The customer confirmed that the patient sample was rerun again later before advising any treatment.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facslyse wash assistant user¿s guide, #23-11113-01, rev.1/vers.A.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 a potential cause of the erroneous results was an incorrect volume of solution being used during instrument operation.An investigation was performed by the fses to understand the workflow with the instrument and they found that the customer was using a higher volume of lysis solution than was recommended by bd.The fses determined that the cell loss was due to the extravasation of the excess volume during the sample preparation process.After determining the issue and analyzing initial tests, they found that a reduction of the lysis solution and increase in incubation time would result in the desired cell concentration.A new lwa protocol was designed for the processing of the samples on the customer¿s end, and by using this protocol the customer no longer observed cell loss and the instrument was performing as expected.No one was harmed or injured, and no patients were harmed from any potential 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: n/a h3 other text : see h.10.

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that there were cell that were lost in the washers.The following information was provided by the initial reporter: loss of cells was observed in tubes processed in washers (around 50%).

• 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: 15958671
• MDR Text Key: 305628602
• Report Number: 2916837-2022-00362
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• 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