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

Catalog Number 337408

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the cell wash station was leaking outside of instrument with a bd facs¿ lwa.The following information was provided by the initial reporter: cell was station is not draining and is leaking under the instrument.They noticed the issue during shutdown and suspect that the fluid is either clean or di.Customer has put the instrument out of service.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? n/a.What was the fluid that leaked? suspect di water or clean.What is the source of leak -- waste line or non-waste line? cell wash station.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.Software version? unknown.Resolution achieved (y/n)? no.Follow up required (y/n)? yes.

Manufacturer Narrative

H6: investigation summary: ¿ scope of issue: the scope of issue is only limited to part # 337408 - lwa including external tank option, serial # (b)(6).¿ problem statement: customer reported a complaint that the cell wash station is not draining causing a leak at the bottom of the instrument.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 30sep2019 to date 30sep2020.¿ complaint trend: there are 2 complaints related to the issues of the instrument failing to drain and leakage from the bottom of the instrument; pr# 1767611 and this one, 1870018.Date range from 30sep2019 to date 30sep2020.¿ manufacturing device history record (dhr) review: dhr part #337408 serial # (b)(6).File #337146-337146-r337146000729-101146527-16, 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 leak was due to a dirty or clogged waste drain in the cell wash.This resulted in fluid to overflow outside the wash station, onto the counter underneath the instrument.A clogged, dirty, or blocked waste channel can lead to backflow of fluids and cause a leak.The fse (field service engineer) found the cell wash station not draining and confirmed that there was debris buildup at the bottom of the drain but could not verify what the material could have been.He cleared the waste path by manual removal and performed a maintenance cleaning by running a flush through the system.No parts were requested for evaluation as there were no replace parts.The instrument was running as expected after the repair and no individual has harmed nor injured.Although the leak was di water or facsclean waste, there was no skin contact nor was there any medical treatment performed after it was noticed during shutdown.No user was harmed or injured as they used gloves and safety protection to clean up the leak.User¿s should wear proper ppe (personal protective equipment) especially handling biological waste, as cautioned in the user guide; bd facslyric¿ clinical system instructions for use, #23-1113-00, page 107.After the repair, the instrument was rebooted, tested and functioning as expected.The safety risk is low as there was no impact to customer health or safety.¿ service max review: review of related work order #: 01627655, case # 01149973 install date: 26dec2016 defective part number: n/a work order notes: o subject / reported: cell was station is not draining and is leaking under the instrument.O problem description: cell was station is not draining and is leaking under the instrument.They noticed the issue during shutdown and suspect that the fluid is either clean or di.Customer has put the instrument out of service.O work performed: the bottom of the wash well was clogged with an acrylic type of debris buildup blocking the waste channel and partially filling the channel in.The buildup was removed and the channel cleared mechannically and by flushing.The instrument was tested and verified as working to specs.No parts were necessary for repair.O cause: the cause of the buildup and clog could not be determined.O solution: performing to specs.¿ returned sample evaluation: a return sample was not requested because no parts were replaced.¿ risk analysis: risk management file part # 337408fmea, revision 01, bd facs¿ lyse/wash assistant failure mode and effects analysis (fmea) was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? ¿yes ¿no o id: 2 o item: wash o function: improper wash o potential failure mode: cell wash tank empty o potential causes: loss of communication between float sensor and controller board a o local and next-level effects: improper washing o hazards: sample improperly prepared o end effects: delayed or no results o probability: 2 o severity: 2 o risk index: 4 o risk controls: n/a o effectiveness verification: mitigation(s) sufficient ¿yes ¿no ¿ root cause: based on the investigation results the root cause was due to a dirty and clogged waste drain in the cell wash.¿ conclusion: based on the investigation results, the root cause of the leak on the lwa instrument was due to a clogged waste drain in the cell wash.The fse confirmed the issue, cleared the debris and performed a complete flush.After the repair, the instrument was rebooted, tested and functioning as expected.The safety risk is low as there was no impact to customer health or safety.H3 other text : see h10.

Event Description

It was reported that the cell wash station was leaking outside of instrument with a bd facs¿ lwa.The following information was provided by the initial reporter: cell was station is not draining and is leaking under the instrument.They noticed the issue during shutdown and suspect that the fluid is either clean or di.Customer has put the instrument out of service.1.Was the leak contained within the instrument? n 2.Was the leak in a customer accessible location? n/a 3.What was the fluid that leaked? suspect di water or clean 4.What is the source of leak -- waste line or non-waste line? cell wash station 5.Was the customer exposed to blood or bodily fluids? n 6.Was there any physical harm to the customer as a result of the leak n software version? unknown resolution achieved (y/n)? n follow up required (y/n)? y.

• 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
• MDR Report Key: 10705898
• MDR Text Key: 231446646
• Report Number: 2916837-2020-00200
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 06/27/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other