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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs¿ lyse wash assistant that the customer noticed a contamination in the tubes within the same series.The following information was provided by the initial reporter.It was reported by the customer noticed a contamination in the tubes within the same series.The customer noticed a contamination in the tubes within the same series, it is about a problem of rinsing of the nozzle of washing.

Manufacturer Narrative

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 investigation summary 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 a complaint regarding contamination.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2021 to (b)(6) 2022.Complaint trend: there are 21 complaints related to the issue of contamination; date range from (b)(6) 2021 to (b)(6) 2022.Manufacturing device history record (dhr) review: dhr part #337146 serial # (b)(6), file # (b)(6), 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 contamination was a faulty compressor.The customer reported contamination in the tubes within the same series.They experienced problem of rinsing the washing nozzle.The field service engineer (fse) performed a series of works including checking the pressure of the compressor outlet, recalibrating the vacuum calibration, replacement of bal seal (b)(6), performing reliability tests on the tubes.The fse confirmed that the compressor was out of specification and proceeded to replace it (b)(6).After the series of works performed the instrument was performing as intended.No patient was treated nor harmed from incorrect results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facs¿ lyse wash assistant system instructions for use, #23-11113-00 rev.1/vers.A, page 101.The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2020.Defective part number: 64489607 - lwa compressor service assembly.Work order notes: subject: (b)(6) - bd facs lyse wash assistant - contamination problem.Problem description: the customer noticed contamination in the tubes within the same series, it is a problem of rinsing the washing nozzle.Work performed: 20/09/22: compressor outlet pressure check: pressure less than 39 psi : non-compliant, out of specification.Recalibration "vacuum calibration" compliant after modifications.Reproduction of the error "tube engagement fault" 2 times during reliability test, the error is intermittent.Compressor replacement to be planned.26/09/22 : replacement of the compressor (b)(6).Output pressure check : 41 psi, compliant.Verification of vacuum calibration: compliant.Replacement of the bal seal (b)(6).Reliability test on 5 then 10 tubes x2: compliant.Functional device and compliant according to bd specifications.Cause: faulty compressor, out-of-specification flow.Solution: compressor replacement.Returned sample evaluation: a return sample was not requested because part replaced is not returnable and was discarded.Risk analysis: risk management file part # 10000597659, rev.03 /vers.C, bd facs¿ lyse wash assistant risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Id: 3.1.1 , hazard: carryover , cause: dirty spindle, harmful effects: inaccurate results, residual probability: 1 , residual severity: 3 , residual risk index: 3.Root cause: based on the investigation results the root cause of the customer observing contamination was a faulty compressor.Conclusion: based on the investigation results, the root cause of the customer observing contamination was a faulty compressor.The field service representative (fse) performed a series of works including checking the pressure of the compressor outlet, recalibrating the vacuum calibration, replacement of bal seal (b)(6), performing reliability tests on the tubes.The fse confirmed that the compressor was out of specification and proceeded to replace it.After the series of works performed the instrument was performing as intended.

Event Description

It was reported that while using bd facs¿ lyse wash assistant that the customer noticed a contamination in the tubes within the same series the following information was provided by the initial reporter: it was reported by the customer noticed a contamination in the tubes within the same series.The customer noticed a contamination in the tubes within the same series, it is about a problem of rinsing of the nozzle of washing.

• 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
• 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: 15590244
• MDR Text Key: 302335918
• Report Number: 2916837-2022-00295
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/09/2022

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: 09/16/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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