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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that waste leaked outside of instrument with a bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: leaking at the quick connect.Was the leak liquid 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? unknown.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontaminate/bleach? no.Was the customer/ bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

H6 investigation summary: scope of issue: the scope of issue is only limited to bd facs lyse wash assistant part # 337146, serial # (b)(6).Problem statement: customer reported complaint of waste leakage, without bleach, outside of the instrument.Manufacturing defect trend: there are no other qns (quality notifications) related to the reported issue.Date range from 01oct2019 to date 01oct2020.Complaint trend: there are 3 complaints related to the issue of waste leakage without bleach outside of the instrument; date range from 01oct2019 to date 01oct2020.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 waste leakage, without bleach, outside of the instrument was due to a worn male and female waste connector from the line of the waste tank.The fse (field service engineer) confirmed the issue when he noticed the leak at the connection, however it was being contained in the tank tray below.The fse replaced both connection parts, 59-10091-04 - cpln bdy pnl mt 1/16 id org and 59-10090-05 - coupl ins hose barb pp orn, which resolved the issue.No parts were requested for evaluation as the connectors are not returnable were discarded.After the repair the instrument was performing as expected.Although the leak was waste and the potential exposure to biohazard material, there was no skin contact nor was there any medical treatment performed.No user was harmed or injured as both the customer and fse wore ppe (personal protective equipment) to avoid coming in contact with the fluid.User¿s are cautioned to wear proper ppe, especially handling biological waste as stated in the bd facs lyse wash assistant user¿s guide, which can be found starting on chapter 7: maintenance, on 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 #: (b)(4), case # (b)(4).Install date: (b)(6) 2011.Defective part number: 59-10091-04 - cpln bdy pnl mt 1/16 id org, 59-10090-05 - coupl ins hose barb pp orn.Work order notes: subject / reported: waste bottle quick connector is leaking.Problem description: leaking at the quick connect.Work performed: i observed complaint of fluid dripping out of the waste line/tank quick disconnect fitting and pooling in the tray under the bottle.I proceeded to allow the user to sanitize the contaminated area, and then replaced the male and female waste line/tank quick disconnect fitting.Cause: cracked component.Solution: system function has been restored, no further malfunction related to this repair or otherwise observed.This device creates no documentation.Returned sample evaluation: a return sample was not requested because the replaced parts are not returnable and were discarded.Risk analysis: risk management file part # 337146fmea, rev.03/vers.C, lyse wash assistant fmea disinfectant project was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes no.Id:(b)(4).Item: bd disinfectant.Function: contain the waste.Potential failure mode: integrity of waste tank compromised.Potential causes: incompatibility of antifoam with pp waste tank material.Local and next-level effects: waste leaks out of the tank.Hazards: chemical/biohazard due to incompatible material/chemical reaction.Risk controls: disinfectant added to waste tank; samples lysed and/or fixed; anti-foam msds.Effectiveness verification: refer to memo: steris vesta syde sq product chemical compatibility with anti-foam and waste tank.Probability: 1.Severity: 4.Risk index: 4.Output: none.Mitigation(s) sufficient: yes / no.Root cause: based on the investigation results the root cause was due to worn male and female waste line/tank quick disconnect fitting.Conclusion: based on the investigation results, the root cause of waste leakage, without bleach of the facs lyse wash assistant was due to worn male and female waste line/tank quick disconnect fitting.The fse confirmed the issue, replaced the parts, and fixed the leak.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 biohazardous fluid.The safety risk is low there was no impact to customer health or safety.

Event Description

It was reported that waste leaked outside of instrument with a bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: leaking at the quick connect.1.Was the leak liquid 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? unknown.5.Did biohazard leak before or after waste line? after waste line.6.Was the waste mixed with decontaminate/bleach? no.7.Was the customer/ bd personnel physically in contact with the fluid? no.

• 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
• MDR Report Key: 10711888
• MDR Text Key: 247658138
• Report Number: 2916837-2020-00203
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• 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: 08/12/2021

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 Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1