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 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: station, pipetting diluting clinical use.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 the bd facs¿ lyse wash assistant that there was carryover.The following information was provided by the initial reporter: customer would like instrument check to ensure that carry over fault as reported on case ref: (b)(4) will not return.Dirty tubing identified between the pbs container.(b)(6) 2022, safety checklist available please see attachment.[(b)(6): additional questions asked by bduk technical service on (b)(6)]: can you please confirm the following: were any patient sample effected? was any course of treatment changed as a result of erroneous results? was any confirmatory testing completed? [customer responses of (b)(6)]: no erroneous results were authorised or affected patient care, however there were several near-misses that were identified by our stringent, in place quality checks.Confirmatory testing and repeat testing was performed on each time the carryover was detected.

Event Description

It was reported that while using the bd facs¿ lyse wash assistant that there was carryover.The following information was provided by the initial reporter: customer would like instrument check to ensure that carry over fault as reported on case ref: (b)(4) will not return.Dirty tubing identified between the pbs container.5 december 2022 - safety checklist available.[22 december - (b)(4): additional questions asked by bduk technical service on 19 december]: can you please confirm the following: were any patient sample effected? was any course of treatment changed as a result of erroneous results? was any confirmatory testing completed? [customer responses of 22 december]: no erroneous results were authorised or affected patient care, however there were several near-misses that were identified by our stringent, in place quality checks.Confirmatory testing and repeat testing was performed on each time the carryover was detected.

Manufacturer Narrative

H.6 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 regarding recurring carryover on 29sep2022.The customer identified dirty tubing between the pbs container and wanted to check the instrument for carry over.This poses the risk of producing 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 04dec2021 to 04dec2022.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.Complaint history review: there are 13 complaints related to as reported code.1: contamination ¿ carryover; date range from 04dec2021 to 04dec2022.Returned sample analysis: a return sample was not requested for evaluation because the potential cause of the issue was determined using the servicemax review.After the repairs/replacements, the instrument was found to be performing as intended.Service history review: review of related work order #: 02649881, case # (b)(4).Install date: 15apr2015.Defective part number: 64844909 - face seal/ball seal/4th stage assy rep.648195 - valve 2/2 24vdc 1.4mm 3in wire.64971307 - kit upgrd pm lwa.Work order notes: subject / reported: 337146 - bd facs lyse wash assistant - courtesy visit following issue case ref: (b)(4).Problem description: customer would like instrument check to ensure that carry over fault as reported on case ref: (b)(4) will not return.Dirty tubing identified between the pbs container.Work performed: dj 18oct2022 - customer reported that issue had returned.Started instrument and ran cell wash test - similar end volumes in all tubes.Ran air pressure test, vacuum test and cell wash test again - all okay.Visual inspection of instrument - cell wash block 4th stage output blocked and baal seal dirty - cleaned and fitted new tubing and connector - removed black inline restrictor and ran cell wash test with cover off - visually all okay.Ran cell wash test with cover on - all okay.Customer ran their own carry over test - appears okay - agreed to follow up with customer to ensure issue is resolved.Dj 09nov2022 - issue had re-occurred per correspondence with customer.Replaced cell wash 4th stage and v9 and v6 valves (pn: 64844909 and pn: 648195 x2 from car stock ts 730).Replaced valve stack tubing.Replaced cell wash block o-rings, motor pulley belt and spindle baal seal from pm kit (pn: 64971307 from car stock ts 730).Carried out performance verification: touch screen, tank sensing, lyse/fix dispense, manual decontamination, power supply voltage, carousel and tube scanning, air pressure test, vacuum calibration, vacuum test, cell wash test - all okay - within specifications.Repair intervention completed successfully.Cause: dj 09nov2022 - not washing spindle properly.Solution: replaced cell wash 4th stage (pn: 64844909 and 648195 x2 from car stock ts 730).Parts replaced: 64844909 - face seal/ball seal/4th stage assy rep.648195 - valve 2/2 24vdc 1.4mm 3in wire.64971307 - kit upgrd pm lwa.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 or no? id: 3.1.1.Hazard: carryover.Cause: dirty spindle.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 faulty washing of the spindle and 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 faulty washing of the spindle and faulty cell wash.The customer reported complaint regarding recurring carryover.The customer identified dirty tubing between the pbs container and wanted to ensure that carryover issue from case : 01772315 would not reoccur.The field service representative (fsr) performed a series of works in the initial visit including: starting the instrument and performing successful tests of cell wash, air pressure and vacuum.Upon visual inspection, the fsr confirmed that 4th stage output of the cell wash was blocked and the bal seal was dirty.The fsr proceeded to clean the components and fitted new tubing and connector.They also removed the black inline restrictor and ran successful cell wash tests with cover on and off.The customer ran their own successful carry over test.Per correspondence of the fsr with the customer, the issue reoccurred.The fsr then proceeded to replace components including: cell wash 4th stage and v9 and v6 valves (pn: 64844909 and pn: 648195 x2 from car stock ts 730), valve stack tubing, cell wash block o-rings, motor pulley belt and spindle bal seal from pm kit (pn: 64971307 from car stock ts 730).They then carried out performance verification: touch screen, tank sensing, lyse/fix dispense, manual decontamination, power supply voltage, carousel and tube scanning, air pressure test, vacuum calibration, vacuum test, cell wash test.After the series of replacements and works performed, the instrument was confirmed to be performing as intended and per specifications.Although erroneous results were obtained, these were not 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 was determined to be faulty washing of the spindle and faulty cell wash.The customer reported complaint regarding recurring carryover.The fsr performed a series of works including: cleaning components and replacing cell wash 4th stage and v9 and v6 valves (pn: 64844909 and pn: 648195 x2 from car stock ts 730), valve stack tubing, cell wash block o-rings, motor pulley belt and spindle bal seal from pm kit (pn: 64971307 from car stock ts 730).After the series of replacements and works performed, the instrument was tested and confirmed to be performing as intended and per specifications.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.

• 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 INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16118306
• MDR Text Key: 308826394
• Report Number: 2916837-2023-00001
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/13/2023

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: 11/23/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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