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

Catalog Number 337408

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

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd facs¿ lwa that the lwa is producing 50% less viable stained cells.The following information was provided by the initial reporter: it was reported by the customer that this lwa is producing 50% less viable stained cells.

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: (b)(6).

Manufacturer Narrative

H.6 investigation summary: scope of issue: the scope of issue is only limited to lwa including external tank option, part#: 337408 and serial#: (b)(6).Problem statement: customer reported complaint regarding losing cells on (b)(6) 2022.This poses the risk of producing delayed or erroneous results that might impact patient diagnosis and treatment.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 14oct2021 to 14oct2022.Device history record (dhr) review: dhr part#: 337408, serial#: (b)(6), file#: (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 7 complaints related to as reported code 1: result ¿ unexpected; date range from 14oct2021 to 14oct2022.Returned sample analysis: the return sample was received and evaluated.It was found that there was corrosion on the components due to fluidic spill.The cell wash was repaired and passed testing.Service history review: review of related work order#: (b)(4).Install date: on (b)(6) 2020.Defective part number: 648617 - assy cell wash mechanism blue.Work order notes: subject / reported: losing cells, problem description: losing cells, work performed: replaced cell wash and customer ran samples and found no issues.Cause: cell wash was spinning at different speeds inconsistently for each tube solution: replaced cell wash parts replaced: 64861719 - assy cell wash mechanism blue repaired.Labeling / packaging review: n/a.Risk analysis: risk management file part#: 10000597659, rev.03/vers.C, ra bd facs lyse wash assistant was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes, no.Id: (b)(4).Hazard: 1.Un-prepped sample.2.No answer.3.Loss of sample.4.Safety biohazard.Cause: defective valves harmful effects: inaccurate results, residual probability: 1, residual severity: 3, residual risk index: 3.Potential causes: based on the investigation results, the potential cause was determined to be a faulty cell wash.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause was determined to be a faulty cell wash.The customer reported a complaint regarding losing cells.The instrument was producing 50% less viable stained cells.The field service representative (fsr) confirmed that the cell wash was defective.This resulted in the cell wash spinning at different speeds inconsistently for each tube.The fsr proceeded to replace the cell wash.After the replacement, the instrument was performing as expected.Although unexpected results were obtained, there were no erroneous results, and this were not reported to the clinician.The instrument was being validated by the customer.No patients were treated or harmed using the results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant user¿s guide, #23-11113-00 rev.1/vers.A, page 101.Conclusion: based on the investigation results, complaint was confirmed and the potential cause was determined to be a faulty cell wash.The customer reported a complaint regarding losing cells.The field service representative (fsr) confirmed that the cell wash was defective.The fsr proceeded to replace the cell wash.After the replacement, the instrument was performing as expected.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.

Event Description

It was reported that while using the bd facs¿ lwa that the lwa is producing 50% less viable stained cells.The following information was provided by the initial reporter: it was reported by the customer that this lwa is producing 50% less viable stained cells.

• Brand Name: BD FACS¿ LWA
• 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: 15642599
• MDR Text Key: 307200056
• Report Number: 2916837-2022-00313
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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 Catalogue Number: 337408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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