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 Fluid/Blood Leak (1250)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs¿ lyse wash assistant there was leakage of biohazardous fluid.The following information was provided by the initial reporter: "was the leak fluid or air?" "liquid." "was the leak contained within the instrument?" "not contained." "was there spray of fluid under pressure?" "no." "what was the fluid that leaked?" "biohazard." "did biohazard leak before or after waste line?" "before waste line." "was the waste mixed with decontamination or bleach?" "no." lwa is leaking from the bottom and not the tank area.Unacceptable vacuum leakage fault.Customer noticed the spindle well still had liquid after run.The manual drain switch did not drain out.Liquid was found underneath instrument.

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: 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 leakage of biohazard not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue for part#: 337146.Date range from 01aug2021 to 01aug2022.Complaint trend: there are 2 complaints related to a fluidic leak due to a valve issue for part # 337146;date range from 01aug2021 to 01aug2022.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.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 leakage of biohazard not contained within the instrument was a loose valve not opening and closing completely.The customer reported that the spindle well still had liquid after a run causing liquid leakage underneath the instrument.As part of an onsite visit, the fse (field service engineer) confirmed the issue and found that some screws that held the body of the valve responsible for draining the spindle well were loose, which prevented the valve from fully opening and closing.This then caused the overfilling and incomplete draining of the spindle well and vacuum leakage.The fse removed the valve, checked the alignment and operation, and re-assembled and re-inserted it.During this primary repair, the fse encountered a secondary unrelated issue with a lyse pump initialization error, which was resolved by replacing the module a controller pcb and will be addressed in a separate complaint (pr 5769057).After the valve repair, the valve was able to fully open and close and the instrument was found to be performing as expected with no further leaks.Although the leaked fluid was biohazardous, no customer or bd personnel came in direct contact with the fluid, and no one was harmed or injured due to the leak.Moreover, there was no spray of fluid under pressure, thereby decreasing the exposure.Users should wear suitable ppe (personal protective equipment), especially while handling biological material as stated in lwa¿s instructions for use (ifu).Proper daily and monthly cleaning procedures can be found in the bd facs¿ lyse wash assistant instructions for use, 23-11113 rev.02/vers.A, starting on page 107 (maintenance).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: on (b)(6) 2011.Defective part number: n/a.Work order notes: subject / reported: unacceptable vacuum leakage fault.Problem description: unacceptable vacuum leakage fault.Customer noticed the spindle well still had liquid after run.The manual drain switch did not drain out.Liquid was found underneath instrument.Work performed: found that the valve responsible for draining the spindle rinse shroud had a couple of loose screws that hold the body of the valve together.The valve was therefore unable to fully open/close.This was the cause of both the filling/overfilling rinse shroud and the vacuum leakage.I remove the valve, checked alignment and operation and re-assembled it.The valve was then able to fully open/close as expected.Cause: valve for spindle rinse shroud drain was not able to fully open/close.Solution: after repairing the loose valve and replacing the failed pcb, the issues have been resolved.The instrument is operating as intended and is testing without errors.I have returned the instrument to the lab for normal use.Returned sample evaluation: a return sample was not requested for evaluation because no parts were replaced during the repair for the leakage.Risk analysis: risk management file part#: 337146ra, vers.B, 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.Hazard id: 3.1.2.Hazard: 4.Safety biohazard.Cause: defective valve.Harmful effects.1.Delayed or no results.2.Increased cost of test due to need to re-prep then rerun.3.Poor reliability.4.Blood exposure is higher risk without fixative.Residual severity: 3.Residual probability: 1.Residual risk index: 3.Root cause: based on the investigation results, the root cause of the leakage was a loose valve in the spindle well not opening and closing completely.Conclusion: based on the investigation results, the root cause of the leakage of biohazard not contained within the instrument was a loose valve in the spindle well not opening and closing completely.The customer reported that the spindle well still had liquid after a run causing liquid leakage underneath the instrument.During their onsite visit, the fse confirmed the issue and found that some screws that held the body of the valve responsible for draining the spindle well were loose, thus preventing the valve from fully opening and closing.The fse removed, realigned, and reassembled the valve.After the repair, the valve was able to fully open and close and the instrument was found to be performing as expected with no further leaks.Although the leaked fluid was biohazardous, no customer or bd personnel came in direct contact with the fluid, and no one was harmed or injured due to the leak.The safety risk of this hazard has been identified to be within the acceptable level.Supporting document: n/a.

Event Description

It was reported that while using bd facs¿ lyse wash assistant there was leakage of biohazardous fluid.The following information was provided by the initial reporter: "1.Was the leak fluid or air? liquid.2.Was the leak contained within the instrument? not contained.3.Was there spray of fluid under pressure? no.4.What was the fluid that leaked? biohazard.5.Did biohazard leak before or after waste line? before waste line.6.Was the waste mixed with decontamination or bleach? no."7.Was the customer/bd personnel physically in contact with the fluid? no.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin." lwa is leaking from the bottom and not the tank area.Unacceptable vacuum leakage fault.Customer noticed the spindle well still had liquid after run.The manual drain switch did not drain out.Liquid was found underneath instrument.".

• 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: 15237443
• MDR Text Key: 300677149
• Report Number: 2916837-2022-00217
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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: 08/01/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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