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: bd facs¿ lyse wash assistant.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Was reported that while using the bd facs¿ lyse wash assistant that there was carryover.The following information was provided by the initial reporter: (b)(6) : (b)(6) 2022 12:42:26 (gmt).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): 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.

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: the customer reported a complaint regarding carryover issues that occurred on (b)(6) 2022.Carryover 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 no users or patients were harmed due to this issue.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue for part # 337146.Date range from 04dec2021 to date 04dec2022.¿ 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.¿ complaint history review: there are 14 complaints related to the issue of carryover for part # 337146; date range from (b)(6) 2021 to date (b)(6) 2022.¿ returned sample analysis: a return sample was not requested for evaluation because the potential cause of the carryover was determined using the servicemax review.After the repairs/replacements, the instrument was found to be functioning as expected.¿ service history review: review of related work order #: (b)(4); case # (b)(4) install date: 19jul2018 defective part number: o 64844909 - face seal/ball seal/4th stage assy rep o 64845019 - assy valve stack blue repaired work order notes: o subject: 337146 - bd facs lyse wash assistant - courtesy visit following issue case ref: (b)(4) o 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 o work performed: o dj (b)(6) 2022 - investigated issue and protocols - visual inspection shows build up of residue in tubing.Replaced 4th stage assembly (pn: 64844909 from car stock ts 730), tubing and flushed system - ran cell wash test - all okay - left with customer to monitor.O (b)(6) 2022 - issue reoccurred - replaced valve stack assembly (pn: 64845019 from car stock ts 730).Carried out performance verification: touch screen calibration, carousel / tube sensing, tank sensors, vacuum calibration, vacuum test, air pressure test, dispense lyse/fix, cell wash test and manual purge of cell wash spindle - all okay.Repair intervention completed successfully.O cause: dj (b)(6) 2022 - not washing spindle properly o solution comments: dj (b)(6) 2022 - replaced 4th stage assembly and valve stack assembly (pn: 64844909 and 64845019 from car stock ts 730).¿ labeling / packaging review: n/a ¿ 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.Hazard(s) identified? yes no o hazard id #: 3.1.1 o hazard: carryover o cause: dirty spindle o harmful effects: inaccurate results 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 the spindle not washing properly.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, the potential cause was determined to the spindle not washing properly.In response to the customer¿s complaint regarding carryover, an fse (field service engineer) went onsite and confirmed the issue.The fse first identified a build of residue in some tubing and replaced the 4th stage assembly and its tubing (part # 64844909 - face seal/ball seal/4th stage assy rep) and flushed the system.After the issue persisted, the fse also replaced the valve stack assembly (64845019 - assy valve stack blue repaired) and performed a manual purge of the cell wash spindle.The fse also carried out various other calibrations and performance checks including touchscreen, carousel, tank sensor calibration, and vacuum, air pressure, dispense lyse/fix, and cell wash tests.After these repairs, the instrument was found to be functioning as expected with no further carryover.After this case, there have been no other cases related to carryover for this instrument.Although carryover issues pose the risk of erroneous results, the customer confirmed that no results were reported to clinicians.Thus, no patients were harmed or treated based on the erroneous 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.The safety risk of this hazard has been identified to be within the acceptable level.¿ conclusion: based on the investigation, the complaint was confirmed and the potential cause of the carryover was determined to be the spindle not washing properly.The fse replaced the 4th stage assembly (part # 64844909), valve stack assembly (part # 64845019), and tubing which resolved the issue.The fse also performed a series of calibrations and tests, and after these repairs and checks, the instrument was found to be working as per bd specifications.No erroneous results were reported to clinicians and no patients were harmed due to the carryover issue.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.¿ supporting document: n/a.

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: (b)(6) : (b)(6) 2022 12:42:26 (gmt) 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.[22 december - (b)(6): 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.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16118309
• MDR Text Key: 308831856
• Report Number: 2916837-2023-00002
• 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: 03/29/2023

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: 11/09/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• 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