MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; SEE H.10

Model Number 337146

Device Problem Contamination (1120)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

D3: common device name: station, pipetting diluting clinical use.H3: 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 bd facs¿ lyse wash assistant that there was carryover.The following information was provided by the initial reporter: as i mentioned to you over the phone yesterday, our washers continue to give dragging problems creating problems/errors in the reporting phase.I think it is imperative to find a solution given the necessity of having reliable results for all types of pathology.

Manufacturer Narrative

The following fields have been updated with corrected information: h6.Event problem and evaluation codes: patient annex code f26.¿ 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 washers that create errors in reporting phase which occurred on 31mar2023.Carryover involving patient samples has the potential to adversely affect test results and give an inaccurate readout.The instrument underwent repairs and was found to be functioning as expected, and neither the customer nor any patients were harmed by these results.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 31mar2022 to 31mar2023.¿ complaint history review: there are 14 complaints related to the issue of carryover issue; pr# (b)(4).Date range from 31mar2022 to 31mar2023.¿ 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.Date of mfg: 03feb2022.¿ returned sample evaluation: a return sample was not requested for evaluation because replaced part was not service returnable.After the repairs the instrument was found to be functioning as intended.¿ service history review: review of related work order # 02911726, case #: (b)(4).Install date: 18may2022.Defective part number: filter restrictor- pn 342619.Work order notes: o subject: 337146 - bd facs lyse wash assistant - carryover.O description: n/a.O work performed: fse performed troubleshooting, fluidics leaks check, leak tests on pneumatic system, valve functionality check, calibration, and leak test on vacuum, probe rinsing check on cell wash assembly, lyse and fix solution dispensing functionality check, tank sensor functionality check and replaced filter restrictor 342619.A final inspection was performed which includes reliability test with food coloring and checking system attributes in bd instrument database.The instrument is performing within the expected specifications and is ready to use without restrictions.O cause: filter restrictor clogged.O solution: replaced part not in stock, after various tests by the application specialist the lwa tool appears to work correctly, the problem was caused by the pbs-bsa solution used by the customer.O parts replaced: filter restrictor- pn 342619.¿ 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 or no? o hazard id #: 2.1.1.O hazard: carryover.O cause: clogged orifice.O harmful effects: 1.Incorrect results.2.Damaged instrument.O residual probability: 1.O residual severity: 3.O residual risk index: 3.¿ potential causes: based on the investigation, the potential cause was determined to be pbs-bsa solution used by the customer.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and service activity review, the potential cause was determined to be pbs-bsa solution used by the customer.An fse (field service engineer) went onsite and confirmed the issue.To resolve this issue, the fse performed troubleshooting measures and checks which included fluidics leakage tests pneumatic system leak test, proper functioning of valves, vacuum leak test and vacuum calibration.In addition, the fse also verified probe rinsing for cell wash assembly, lyse and fix solution dispensing functionality and tank sensor testing.During troubleshooting, the fse found filter restrictor to be clogged and replaced the part.Afterwards, fse performed reliability test and the instrument was functioning as expected.To further determine the potential cause of filter restrictor being clogged, application specialist were contacted and after various testing, the potential cause was determined and after replacement of the pbs-bsa solution, the instrument was found to be functioning as expected.The fse confirmed that erroneous results on patient samples were not reported to the clinicians.No patient was diagnosed or treated based on these results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant instructions for use, #23-11113 rev.02/vers.A, starting page 107.Troubleshooting procedures can be found in the ifu starting on page 145.The safety risk of this hazard has been identified to be within the acceptable level.¿ conclusion: based on the investigation, the complaint was confirmed.The potential cause of the issue was determined to be pbs-bsa solution.The fse replaced the clogged filter restrictor and the pbs-bsa solution used by the customer and after subsequent testing, the instrument was functioning as expected.No one was harmed or injured, and no patients were harmed from 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.H3 other text : see h.10.

Event Description

It was reported that while using bd facs¿ lyse wash assistant that there was carryover.The following information was provided by the initial reporter: as i mentioned to you over the phone yesterday, our washers continue to give dragging problems creating problems/errors in the reporting phase.I think it is imperative to find a solution given the necessity of having reliable results for all types of pathology.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Type of Device: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16753675
• MDR Text Key: 313433744
• Report Number: 2916837-2023-00093
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/15/2023

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: 04/11/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1