MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD

Catalog Number 663029

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/08/2022

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.

Event Description

It was reported that the bd facslyric¿ 3l12c instrument ceivd leaked waste fluid outside the instrument.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "the sample line is leaking and the cst will not pass due to the vacuum pressure being out of range." was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.Was there spray of fluid under pressure ? no.What was the fluid that leaked? non-biohazard.What is the source of leak - waste line or non-waste line? waste line.Leak is before or after waste line? after.Was the customer exposed to biohazard fluids? no.

Event Description

It was reported that the bd facslyric¿ 3l12c instrument ceivd leaked waste fluid outside the instrument.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "the sample line is leaking and the cst will not pass due to the vacuum pressure being out of range." was the leak fluid or air? fluid; was the leak contained within the instrument? no; was the leak in a customer accessible location? yes; was there spray of fluid under pressure ? no; what was the fluid that leaked? non-biohazard; what is the source of leak - waste line or non-waste line? waste line; leak is before or after waste line? after; was the customer exposed to biohazard fluids? no.

Manufacturer Narrative

Investigation summary: ¿ scope of issue: the scope of issue is only limited to facslyric 3l12c instrument ceivd, part # 663029, serial # (b)(6).¿ problem statement: customer reported a complaint of a leakage of biohazard not contained within the instrument.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 08mar2021 to date 08mar2022.¿ complaint trend: there are 7 complaints related to the leakage of biohazard not contained within the instrument; date range from 08mar2021 to date 08mar2022.¿ manufacturing device history record (dhr) review: dhr part #663029, 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 blocked v8 valve tubing.The v8 valve tubing, or pinch valve tubing, is frequently mechanically opened and closed by pinching which can sometimes cause the tubing to stick shut.As this tubing handles the aspiration of fluid from the sit, blockages in this tubing can prevent proper aspiration and lead to carryover and waste leakages.During the remote consultation, the customer explained to the assisting tsr (technical service representative) that the sample line was leaking and the cst would not pass due to the vacuum pressure being out of range.They had attempted a log clean, resetting the laser delay, and replacing the sheath filter with no improvement.The tsr identified the issue to be due to a blockage in the v8 pinch valve tubing and this repair was performed in (b)(4).After the repairs, the instrument was performing as expected with no further leakage.No parts were requested for evaluation as there were no parts replaced.Although a leakage of waste material poses a hazard of contamination upon contact, the customer confirmed that they were not harmed in any way.Additionally, the leakage was not under pressure and thus did not increase the risk of exposure.Proper daily and monthly cleaning and maintenance can help in maintaining an optimal system, and can be found in the bd facslyric¿ clinical system instructions for use, #23-19938-02 rev.1/vers.A.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: 02363882, case # 01623278 install date: (b)(6) 2019.Defective part number: n/a.Work order notes: subject / reported: 663029 - facslyric 3l12c instrument ceivd - sample line issue.Problem description: 663029 - facslyric 3l12c instrument ceivd - the sample line is leaking and the cst will not pass due to the vacuum pressure being out of range.Customer already performed a long clean, reset laser delays and replaced the sheat filter¿ however the issue remains.After this, the cst did pass successfully last friday, however this morning, the issue was back and users cannot rely on this heavily used instrument.Internal notes: (b)(6) 2022-03-08 08:13:18z: for dispatch, issue is caused by v8 tubing not opening during sit flush.Requested fse intervention.A separate case will be opened for the 'vacuum pressure out of range' error as they are 2 independent issues.¿ returned sample evaluation: a return sample was not requested because there were no parts replaced.¿ risk analysis: risk management file part # 10000063058ra, rev.07/vers.Aa, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.O azure id: (b)(4).O id: libivd-ra-61 2.1.6.O reg status: ivd; ruo.O hazard: exposure to biological sample.O cause: back drip from injection port (sit).O harmful effects: harm to operator.(exposure to stained sample).O risk control: - sit design to capture back drips.- provide instruction for universal precautions.O req link (azure id): 93132 libivd-did-262 sample preservation during pause.O implementation verification: - lsvn-1008-dp sit backflow control.- libivd-se-15-51ir.O effectiveness verification: - lsvn-1008-dr.- libivd-se-15-51ir.O probability: 1.O severity: 3.O risk index: 3.O residual risk evaluation: a.O new hazards: none.Mitigation(s) sufficient yes no.¿ root cause: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a blocked v8 valve tubing.¿ conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a blocked v8 valve tubing.The issue was identified to be due to a blocked v8 tubing and fse intervention was requested.The blockage was eventually cleared during (b)(4); a separate case focused on a vacuum pressure error.After the repair, the instrument was confirmed to be functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the waste leakage.The safety risk of this hazard has been identified to be within the acceptable level.

• Brand Name: BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD
• Type of Device: NA
• 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: 13950572
• MDR Text Key: 295808509
• Report Number: 2916837-2022-00074
• Device Sequence Number: 1
• Product Code: OYE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 663029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2019
• 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