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

Catalog Number 337408

Device Problem Contamination (1120)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd facs¿ lwa there was carryover.The following information was provided by the initial reporter: #2 carry over (b)(4).They also report carry over and splashed of liquid.

Manufacturer Narrative

Common device name: station, pipetting diluting clinical use.Initial reporter address 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6: 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 carryover on (b)(6) 2023.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 for part # 337408.Date range from 08feb2022 to 08feb2023.Device history record (dhr) review: dhr part # 337408 serial # (b)(6), file # (b)(6), was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 2 complaints for part # 337408 related to as reported code 1: contamination - carry over; (b)(4), and this one, (b)(4).Date range from 08feb2022 to 08feb2023.Returned sample analysis: a return sample evaluation was not requested because the part replaced (pn 342619) in (b)(4) by the field service representative is not returnable.Furthermore, after the works performed, the instrument was confirmed to be performing as intended.Service history review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2020.Defective part number: 64847909 - assy dispense pump blue repaired; 64844909 - face seal/ball seal/4th stage assy rep; (b)(4) - cable canopy harness lwa work order notes: subject / reported: motor error.Problem description: motor error.Work performed: arrived on site to complete a repair on serial number (b)(6)located at (b)(6).I completed the repair as per lwa service manual doc.Number (b)(4).Cause: bad dispense pumps / bad bal seal in 4th stage block.Solution: the instrument is testing without errors and i have returned the instrument to the lab for normal use, unit is operational.Problem 1 = unit was giving intermittent fix pump motion faults.Problem 2 = cell wash solution was being sprinkled over carousel while washing.Problem 1 = replaced the dispense pumps assembly.After replacement the pumps worked properly.Ran several carousels dispensing fix and lyse solutions and got no faults.Problem 2 = the bal seal at the 4th stage block assembly was leaking.The 4th stage block was replaced.After replacement the leak was corrected.Unit was left working properly.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: 3.1.1.Hazard: carryover.Cause: dirty spindle.Harmful effects: inaccurate results.Residual probability: 1.Residual severity: 3.Residual risk: 3 id: 3.1.4.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: 3.Potential causes: based on the investigation results, the potential cause could not be determined.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 could not be determined.The customer reported a complaint regarding motor error (addressed in (b)(4)), splash of liquid (addressed in (b)(4)) and carryover (this one, (b)(4)).The field service representative (fsr) confirmed that that the bal seal at the 4th stage block assembly was leaking.In an attempt to resolve the issue, the fsr proceeded to replace the 4th stage block.After the replacement, the leak was corrected.The instrument was tested after the repair and was confirmed to be performing as expected.Later, in (b)(4), the fsr replaced a semi clogged restrictor, did a check for carryover, and verified the instrument¿s performance.After the works performed, the instrument was functioning as intended.Although carryover was found, no erroneous results were reported to the clinician.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 could not be determined.The customer reported a complaint regarding carryover.In an attempt to resolve the issue, the fsr proceeded to replace the 4th stage block.After the replacement, the instrument was tested and performing as expected.In (b)(4), the fsr replaced a semi clogged restrictor, did a check for carryover, and verified the instrument¿s performance.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.

Event Description

It was reported that while using the bd facs¿ lwa there was carryover.The following information was provided by the initial reporter: #2 carry over (b)(4).They also report carry over and splashed of liquid.

• Brand Name: BD FACS¿ LWA
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16363224
• MDR Text Key: 309602375
• Report Number: 2916837-2023-00033
• 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: 05/24/2023

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: 02/09/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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