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 Contamination (1120)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using a bd facs¿ lyse wash assistant carryover occurred.There was no report of patient impact.The following information was provided by the initial reporter: customer reports carryover issue.The instrument is clean but debris is visualized in facs plots of blank samples.

Event Description

It was reported that while using a bd facs¿ lyse wash assistant carryover occurred.There was no report of patient impact.The following information was provided by the initial reporter: customer reports carryover issue.The instrument is clean but debris is visualized in facs plots of blank samples.

Manufacturer Narrative

H.6.Investigation: 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 carryover issue with the instrument which is clean but debris is visualized in facs plots of blank samples.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 26nov2019 to 26nov2020.Complaint trend: there are 5 complaints related to the issue of carryover issue.Date range from 26nov2019 to 26nov2020.Manufacturing device history record (dhr) review: dhr part #337146 (b)(6), file # 337146-337146-r337146000978-106888788-20, was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the customer observing carryover, especially debris on plots of blank samples, is due to dirty fluidics tanks.It is common for dirt and crystals to build up within the tanks or throughout the system and thus must be cleaned every six months or after an extended period of rest.The customer reported the carryover as they had observed debris on blank samples despite having cleaned the instrument.An fse (field service engineer) was brought onsite and ran tests together with the customer to find the issue.They then swapped the fluidics tanks that looked dirty and samples began to run cleaner until all the tubes ran clean.No parts were requested for evaluation as no parts had to be replaced.After the repair the instrument was tested and was performing as expected.Although the unexpected results were from patient samples, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnosis decision and was reported to bd as not expected.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant system instructions for use, #23-11113-01, page 111.The safety risk is moderate, s3, and there was no impact to patient health or safety.Review of related work order #: 01699637, (b)(4).Install date: 01sep2020.Defective part number: n/a.Work order notes: subject / reported: 337146 - bd facs lyse wash assistant - carryover.Problem description: customer reports carryover issue.The instrument is clean, but debris is visualized in facs plots of blank samples.Work performed: ran test/tubes together with customer, these were then analyzed on a canto2.Containers looked a little dirty, so these were swapped.First sample had some dirt, the next less.Remaining tubes were clean.Cause: most likely crystals and dirt from inactivity; the instrument hadn¿t been used for a few weeks due to previous repairs and validation.Solution: clean containers and flush the tubings thoroughly.Returned sample evaluation: a return sample was not requested because there were no parts replaced.Risk analysis: risk management file part # 337146ra, rev.02/vers.C, bd facs¿ lyse/wash assistant risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Id: 2.1.1.Hazard: carryover.Cause: clogged orifice.Harmful effects: incorrect results, damaged instrument.Risk control: replace orifice at each pm interval.Implementation verification: reliability testing in sv lab; protocol: gppd0010-03 rev a.Effectiveness verification: system characterization summary report lwa carryover evaluation phase iii version 1.0 10/mar/2010.Probability: 1.Severity: 3.Risk index: 3.New hazards: none.Mitigation(s) sufficient yes.No.Root cause: based on the investigation results the root cause was due to a dirty fluidics tank.Conclusion: based on the investigation results, the root cause of the customer seeing carryover between samples is due to a dirty fluidics tank.The fse ran some samples with the customer to observe the issue and found that there was less dirt on the system when using a new tank.They then thoroughly cleaned the fluidics tanks and tubings, and the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk is moderate, s3, and there was no impact to patient health or safety.

• 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
• MDR Report Key: 11047875
• MDR Text Key: 247660622
• Report Number: 2916837-2020-00317
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1