MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD LSRFORTESSA SO

Catalog Number 647177

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that waste leakage occurred outside of instrument during use with a bd lsrfortessa¿ so.The following information was provided by the initial reporter: it was reported that the dcm is dripping.Was there a fluidic leak or spill? yes.No erroneous results, no one was injured in the making of this case & there were no burning smells or odd sounds.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? yes.What was the fluid that leaked/spilled? unknown liquid.Likely a combination of sheath & waste fluid.What is the source of leak/spill? (waste or non-waste line).Combination of both.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.Leak or drip was not under pressure.Additionally, on 2020-8-12 the customer provided the following additional information: in regards to the waste being mixed with bleach or decontaminate, the tsr states, "no".

Event Description

It was reported that waste leakage occurred outside of instrument during use with a bd lsrfortessa¿ so.The following information was provided by the initial reporter: it was reported that the dcm is dripping.Was there a fluidic leak or spill? yes.No erroneous results, no one was injured in the making of this case & there were no burning smells or odd sounds.1.Was the leak/spill contained within the instrument? no.2.Was the leak/spill in a customer accessible location? yes.3.What was the fluid that leaked/spilled? unknown liquid.Likely a combination of sheath & waste fluid.4.What is the source of leak/spill? (waste or non-waste line).Combination of both.5.Was the customer exposed to blood or bodily fluids? no.6.Was there any physical harm to the customer as a result of the leak? no.7.Leak or drip was not under pressure.Additionally, on 2020-8-12 the customer provided the following additional information: in regards to the waste being mixed with bleach or decontaminate, the tsr states, "no".

Manufacturer Narrative

H.6.Investigation: problem statement.Dcm dripping - waste leakage without bleach not contained.Manufacturing defect trend: there are zero quality notifications (qn) related to the reported issue.Date range from (b)(6) 2019 to date (b)(6) 2020.Complaint trend there is one complaint related to the reported issue.Date range from (b)(6) 2019 to date (b)(6) 2020.Service max review: review of related work order #: (b)(4) (case number: (b)(4)).Install date: 15-may-2013.Defective part number: 336504 - two way pinch valve assembly nc.Work order details: subject/reported: dcm dripping.Problem description: dcm dripping, also sample tube ejects/pops out harshly when unloaded with arm to the side.Cause: clogged dcm pump tubing causing sip drip when arm is to the side, v6 valve does not open to vent out the pressure in standby mode (remains closed at all time times), faulty v6 valve.Work performed: fse replaced the dcm pump tubing from a spare stock, flushed the dcm tubing from pump to flowcell to make sure pathway is clear.Fse do not sip drip anymore when arm is to the side.Replaced v6 valve and verified it vents pressure in open state in standby mode and sample tube does not pop put when unloaded.Verified instrument performance with beads, cst performance passed.Solution comments: the reported issue were resolved and instrument is operating normally now.The software version is facsdiva 8.0.1 and no returnable parts were used.Customer will sign and email back the service report to fse at a later time.Returned sample evaluation: defective parts were not returned or requested.The dcm assembly received for mfr# 2916837-2020-00007 was used in this evaluation.Manufacturing device history record (dhr) review: review of dhr part number 647177-647177-h64717700067-100104399-13; serial number (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: a review of risk management file 10000196518, rev 03 - risk analysis ice program was conducted.No new hazard have been identified and the current mitigations are sufficient.Hazard(s) identified: yes.Hazard id: 3.1.5.Hazard: fluidic failure.Cause: leaks from component failure, particularly droplet containment system.Harmful effects: biohazard spill.Initial probability: 1.Initial severity: 5.Initial risk index: 5.Initial risk evaluation: u.Risk control: 1) component spares where applicable.2) manufacturing system testing.Implementation verification: 1) pm spares kit p/n 657678.2) final packaging oms.3) service manual to include section to inspect dcm pressure switch for any leaking.4) fluidics tray will capture any initial leakage.Effectiveness verification: label approval.Residual probability: 1.Residual severity: 5.Residual risk index: 5.Residual risk evaluation: afap (as far as possible).New hazard: none.Mitigation(s) sufficient: yes.Investigation result / analysis: this investigation was performed on defect trend data, complaint trend data, device history record (dhr) review, servicemax review, and risk analysis (ra) review.Based on the location of the leak and the defective component, the two way pinch valve assembly nc (p/n 336504) on the dcm failed.Root cause: defective two way pinch valve assembly nc (p/n 336504).Conclusion: this is not a safety issue.The reported complaint was confirmed by fse.Based from the obtained field information, historical data and performances, there has been no overall safety concerns or user harm/injury during the use of the device and after reporting the incident.The instrument was brought back to functional condition after replacement of the dcm pump tubing from trunk stock, flushed the dcm tubing from pump to flowcell and replaced two way pinch valve assembly nc (p/n 336504).Overall, this incident is not considered as a safety risk.

• Brand Name: BD LSRFORTESSA SO
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10471507
• MDR Text Key: 231685848
• Report Number: 2916837-2020-00100
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 647177
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other