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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

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 running patient sample on a bd facs" lyse wash assistant there ware erroneous results.There was no report of patient impact.The following information was provided by the initial reporter: the customer suspects an issue with the lysing process.The run finishes normally without error messages.Samples look normal upon visual inspection, but upon analysis on the facscanto, the fsc/ssc profile looks squashed.Customer is running the same samples on this and another lwa instrument to compare, and to determine whether the issue is located in the lwa or in the facscanto.Additionally, bd tech provided the following additional information: the readout was indeed on patient samples for clinical use.

Manufacturer Narrative

H6: 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 complaint on squashed cells in fsc/ssc plots.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 11nov2019 to date 11nov2020.Complaint trend: the only complaint related to squashed ceclls in the fsc/ssc plots is this one; date range from 11nov2019 to date 11nov2020.Manufacturing device history record (dhr) review: dhr part #337146 serial # (b)(4), file #(b)(4), 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 why the customer was obtaining unexpected results was due to several faulty components on the instrument.The fse (field service engineer) confirmed the issues after multiple attempts at troubleshooting.The repairs were performed in two different work orders, 01693609 and 01697236, where parts 648478 ¿ bal seal 4th stage, 64971307 ¿ kit upgrade pm lwa, 64937427 - assembly module controller a service and 648443 - cable flex 30 cond folded valve stack bd were replaced.All these parts are not returnable for evaluation and were discared.The fse resolved the issue with no further concerns.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.It was confirmed by the customer that two of their facscanto instruments used for analyzing the patient samples was not the issue, but the preparation with the lwa instrument.After the repairs, the instrument was rebooted, tested and functioning as expected.The safety risk is moderate, s3, and there was no impact to patient health or safety.Service max review: review of related work order #: (b)(4) / (b)(4), case # (b)(4).Transferred to work orders: (b)(4) and (b)(4).Install date: (b)(6) 2018.Defective part number: 648478 ¿ bal seal 4th stage.64971307 ¿ kit upgrade pm lwa.64937427 - assembly module controller a service.648443 - cable flex 30 cond folded valve stack bd.Work order notes: (b)(4) / (b)(4).O subject / reported: 337146 - bd facs lyse wash assistant - cells look squashed on fsc/ssc plot.O problem description: the customer suspects an issue with the lysing process.The run finishes normally without error messages.Samples look normal upon visual inspection, but upon analysis on the facscanto, the fsc/ssc profile looks squashed.Customer is running the same samples on this and another lwa instrument to compare and to determine whether the issue is located in the lwa or in the facscanto.O work performed: (b)(4) 19.Nov.2020 - started instrument.Verified vacuum calibration properly calibrated - all okay.Ran vacuum and air pressure test - all okay.Ran cell wash test - visually inspected tubes - volume in tubes approximately same across all tubes.Ran dispense lyse 900 protocol - lyse pump initialisation fault error message.Requested ltso to create case.Put to further action.(b)(4) 24.Nov.2020 - note: work completed under bd case ref: (b)(4) ((b)(4)) / (b)(4) ((b)(4)).Case can now be closed.Completed service report and emailed to customer.Repair intervention completed successfully.O cause: (b)(4) 24.Nov.2020 - see bd case ref: (b)(4) ((b)(4)) / (b)(4) ((b)(4)).O solution: (b)(4) 24.Nov.2020 - see bd case ref: (b)(4) ((b)(4) / (b)(4) ((b)(4)).Work order notes: (b)(4).O subject / reported: (b)(4) - bd facs lyse wash assistant - lyse pump initialisation fault.O problem description: lyse pump initialisation fault - issue found to be electrical - ribbon cable or controller pcb.O work performed: asc 24/nov/2020: error "lyse pump initialisation".Repacing controller a and ribbon cables.Testing.The instrument is ready to use.O cause: lyse pump initialisation fault - o solution: n/a.Work order notes: (b)(4).O subject / reported: (b)(4) - bd facs lyse wash assistant - lyse washing does not work.O problem description: (b)(4) - bd facs lyse wash assistant - lyse washing does not work.O work performed: asc 24/nov/2020: replacing parts from pm kit (metal block) and bal seal.Testing.Some samples were tested - ok.The instrument is ready to use.O cause: lyse wash assistant - lyse washing does not work.O solution: n/a.Internal notes: o nt 24/11 14:45 requested by (b)(4).O nt 18/11 10:53 (b)(4) to attend tomorrow - eta 9:30-9:45am - emailed (b)(6) confirmation dj 18/nov/2020 - parts allocated and should arrive on-site by today at the latest - requested ltso to plan visit.O (b)(4) 2020-11-16 10:01:08z: rejected, (b)(4) 16.Nov.2020 - morning job finished late, unable to attend for this issue.*non billable - confirmed by (b)(4)* o nt 12/11 14::58 (b)(4) to attend tomorrow - confirmed via email to (b)(4).O nt 12:/11 14:27 waiting to hear back from tc to see whether (b)(4)'s pm tomorrow can be moved.Dries renmans 2020-11-12 11:45:37z: for dispatch, customer ran the same sample on both their lwa instruments, and ran those samples on two different facscanto iis.Sample from the other lwa looks normal on both facscantos.See pdfs in case attachment.The customer would like an urgent intervention since they are unable to cope with only one lwa.O dries renmans 2020-11-11 12:52:16z: further action, helpdesk-await customer response.Customer is testing two lwa instruments and will let us know what the results are later today.Returned sample evaluation: return samples were not requested because the replaced parts are not returnable and were discarded.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.Hazard(s) identified? yes no.O id: (b)(4).O hazard: carryover.O cause: clogged orifice.O harmful effects: incorrect results, damaged instrument.O risk control: replace orifice at each pm interval.O implementation verification: reliability testing in sv lab; protocol: gppd0010-03 rev a.O effectiveness verification: system characterization summary report lwa carryover evaluation phase iii version 1.0 10/mar/2010.O probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.O id: (b)(4).O hazard: loss of sample.O cause: 1.Bad connector.2.Overheated components.3.Insufficient electrical grounding.O harmful effects: delayed results.O risk control: - replaced fci connector with improved molex connector.- added cooling fan and vent holes to the reagent door assembly which resulted in 20 degree reduction to door internal temperature.- added ground cable between reagent door and main chassis to complete chassis ground connection to door.O implementation verification: reliability testing in sv lab; protocol gppd0010-03 rev a o effectiveness verification: systems level reliability test protocol and report o probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the squashed cells in the fsc/ssc plots was due to several faulty components; lyse pump cable and controller, pm kit, and bal seal.Conclusion: based on the investigation results, the root cause of the customer seeing squashed cells in fsc/ssc plots from their analyzer instruments was due to several faulty parts on the lwa.The fse confirmed the issue, replaced the necessary parts and ensured proper performance.After the repairs, 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.

Event Description

It was reported that while running patient sample on a bd facs¿ lyse wash assistant there ware erroneous results.There was no report of patient impact.The following information was provided by the initial reporter: the customer suspects an issue with the lysing process.The run finishes normally without error messages.Samples look normal upon visual inspection, but upon analysis on the facscanto, the fsc/ssc profile looks squashed.Customer is running the same samples on this and another lwa instrument to compare and to determine whether the issue is located in the lwa or in the facscanto.Additionally, bd tech provided the following additional information: the readout was indeed on patient samples for clinical use.

• 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: 10985067
• MDR Text Key: 220970939
• Report Number: 2916837-2020-00299
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/30/2021

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: 11/11/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1