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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

It was reported that while running bd facs¿ lwa liquid sprayed outside of instrument.There was no user impact.The following information was provided by the initial reporter: not aspirating samples correctly.Spray of fluid under pressure not contained within instrument.Leak checklist: was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? yes.What was the fluid that leaked? non biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontaminate/bleach? no.Was the customer/ bd personnel physically in contact with the fluid? no.Where did the physical contact of fluid occur? what personal protective equipment (ppe) was being used during the occurrence? was there any impact to patient samples due to leak? no.

Manufacturer Narrative

Medical device expiration date: na.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 running bd facs¿ lwa liquid sprayed outside of instrument.There was no user impact.The following information was provided by the initial reporter: not aspirating samples correctly.Spray of fluid under pressure not contained within instrument.Leak checklist: was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? yes.What was the fluid that leaked? non biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontaminate/bleach? no.Was the customer/ bd personnel physically in contact with the fluid? no.Where did the physical contact of fluid occur? what personal protective equipment (ppe) was being used during the occurrence? was there any impact to patient samples due to leak? no.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is only limited to lwa including external tank option, part # 337408, serial # (b)(6).Problem statement: customer reported a complaint regarding a spray of fluid under pressure not contained within the instrument.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from (b)(6) 2020 to (b)(6) 2021.Complaint trend: there are 2 complaints related to a spray of fluid under pressure not contained within the instrument.Date range from (b)(6) 2020 to (b)(6) 2021.Manufacturing device history record (dhr) review: dhr part # 337408, 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 biohazard leak was due to a disconnected waste line.The customer had initially submitted a complaint regarding the instrument not properly aspirating the samples, but the fse (field service engineer) responding to the issue also found that the instrument¿s mounting screws were stuck to the base plate.This second issue can be found in complaint# (b)(4).In order to observe the aspiration issue, the fse removed the lwa cover and ran a wash protocol with 6 tubes.During the system priming, the wash tubing spindle had disconnected and sprayed wash solution into the lwa.Due to the amount of pbs that had sprayed into the assembly and pcbs, the fse decided to replace the cell wash assembly.No parts were requested for evaluation as the replaced parts are not returnable and were discarded.After the repair the instrument no longer leaked nor had aspiration issues, and the fse continued with the instrument repair.Although the leakage was in the form of a spray, the customer confirmed that they did not come in contact with the leakage.Additionally, the leaked fluid was found to be non-biohazardous so there was no risk of contamination upon contact.This instrument was not being used for clinical diagnoses at the time of the incident, and thus there was no harm or delay of treatment of any patients.The safety risk is moderate, s3, and there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4) , case # (b)(4).Install date: (b)(6) 2012.Defective part numbers: 64861719 - assy cell wash mechanism blue repaired.346340 - pump liquid 1/8 barb.Work order notes: subject / reported: not aspirating samples correctly.Problem description: not aspirating samples correctly.Work performed: 1.08/19-took cover off of lwa, ran a wash protocol with 6 tubes.During the priming of the system the spindle wash tubing for the cell wash assembly had come off the fitting spraying the wash solution into the lwa.Decided to replace the cell wash assembly due to the amount of pbs that was spraying out and onto the pcbs of the wash assembly.2.08/19-while removing the cell wash assembly the mounting screw tops had rusted off so i was able to remove the original cell wash assembly but could not put in the new cell wash assembly.Could not remove the screws from the base plate.Also tried to remove the dispense assembly and one of the screw tops had rusted off and could not remove the dispense assembly.Ordering a new base plate and dispense assembly.08/20-replaced the base plate, the dispense assembly and the cell wash station.Calibrated the vacuum voltage, checked compressor bleed down rate.Verified cell wash performance and performed the a&p.Cause: 1.Tubing coming off the cell wash assembly.2.Mounting screws stuck in the base plate solution: 1.After replacing the cell wash assembly, lwa is performing within spec.2.After replacing the base plate and dispense assembly, lwa is performing within spec.Internal notes: additional problem was found that requires additional parts.Returned sample evaluation: a return sample was not requested because although the cell wash assembly and assembly probe are returnable, they were not necessary for the investigation.Risk analysis: risk management file part # ra337408, rev.01/vers.A, bd facslyse/wash assistant (lwa) system hazards analysis report was reviewed.No new hazards have been identified and the current mitigations are sufficient.The severity rating in this file is ¿8d¿ based on the previous scale rating.This is equivalent to ¿s4¿ in (b)(4) rev.12/vers.J, whereby the leakage is obvious or indicated by additional (warning) information and hence the impact to the customer is negligible to none.The current mitigations are adequate with rpn under acceptable range.Hazard(s) identified? yes; no.Hazard: safety ¿ biohazard.Target&effect: 2 ¿ spill of sample causes increased blood exposure to operator.Cause: 2.4.5.2 instrument disabled.Basic event: 2.4.5.2.1 waste tubing disconnected.Initial risk: 16d.Risk controls: 1.Better tubing.2.Tubing clamps.Final risk: 8d.Mitigation(s) sufficient: yes; no.Root cause: based on the investigation results the root cause of the leakage of biohazard not contained within the instrument was due to a disconnected waste tubing.Conclusion: based on the investigation results the root cause of the leakage of biohazard not contained within the instrument was due to a disconnected waste tubing.The fse confirmed that the leakage was due to a disconnected waste tubing and replaced the cell wash assembly.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is severe, s4, though there was no impact to the customer health or safety.

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12836525
• MDR Text Key: 282209764
• Report Number: 2916837-2021-00446
• Device Sequence Number: 1
• Product Code: JQW
• 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: 12/06/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/15/2021
• 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