MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿ FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number	342975
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that when the support arm is to the side of a bd facscalibur¿ flow cytometer waste leaks outside of the instrument.There was no user impact.The following information was provided by the initial reporter: the customer reports that the sip backdrips when the tube support arm is to the side.Cleaning the instrument does not resolve the issue.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontaminate/bleach? was the customer/ bd personnel physically in contact with the fluid? no.
Event or Problem Description
It was reported that when the support arm is to the side of a bd facscalibur¿ flow cytometer waste leaks outside of the instrument.There was no user impact.The following information was provided by the initial reporter: the customer reports that the sip backdrips when the tube support arm is to the side.Cleaning the instrument does not resolve the issue.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontaminate/bleach? was the customer/ bd personnel physically in contact with the fluid? no.
Additional Manufacturer Narrative
H.6.Investigation: scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, serial # (b)(6).Problem statement: customer reported a complaint regarding a biohazard leakage not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 18feb2021 to 18feb2022.Complaint trend: there are 11 complaints related to a waste leakage not contained within the instrument.Date range from 18feb2021 to 18feb2022.Manufacturing device history record (dhr) review: dhr part #342975 serial # (b)(6) , file # 342975-e97501090-900165774-08, 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 waste leakage not contained within the instrument was due to a clogged dcm (droplet containment module) tubing.This tubing line is used to help aspirate waste to the waste tank, but any clogs or debris can contribute to leaks or backflow.The customer had initially reported that the sip was dripping, and cleaning the instrument did not resolve the issue.The fse (field service engineer) discovered a clog in the dcm tubing when they tried to clean it.They then replaced the tubing (pn 343585) and confirmed that the instrument was functioning as expected.No parts were requested for evaluation as the replaced part is not returnable and was discarded.Although the leakage was of a biohazardous material that poses the risk of contamination, the customer confirmed that they had not come in contact with the liquid and 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 procedures can be found in the bd facscalibur¿ instructions for use, 23-12911-02 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 #: 02340216, case # (b)(4).Install date: 19sep2008.Defective part number: n/a.Work order notes: subject / reported: sip backdrippping.Problem description: the customer reports that the sip backdrips when the tube support arm is to the side.Cleaning the instrument does not resolve the issue.Work performed: flushed the dcm tubing that passes through the dcm pump and found a clog.Replaced the tubing (nsi pn 343585.) verified dcm operation.Cause: clogged dcm tubing.Solution: the sip is no longer dripping.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 because there were no replaced parts.Risk analysis: risk management file part # 342973-01ra, rev.01/vers.A, bd facscalibur failure mode and effect analysis was reviewed.The current mitigations are adequate with rpn under acceptable range.Hazard(s) identified? yes, no? item: droplet containment module.Function: to contain droplets.Potential failure mode: droplets not contained.Potential effects of failure: all of the sample is.Potential causes/mechanisms of failure: pump not properly sealed.Current controls: n/a.Recommended actions: n/a.Responsible party: n/a.Target completion date: n/a.Actions taken: n/a.Sev: 5.Occ: 5.O det: 1.Rpn: 25.Mitigation(s) sufficient? yes, no? root cause: based on the investigation results, the root cause of the waste leakage was due to a clogged dcm tubing.Conclusion: based on the investigation results, the root cause of the waste leakage was due to a clogged dcm tubing.The fse flushed the tubing that went through the dcm pump and found a clog.The fse replaced the clogged tubing (pn) and confirmed that the instrument was functioning as expected.No one was harmed or injured, and no further leaks occurred.The safety risk of this hazard has been identified to be within the acceptable level.H3 other text : see h.10.

• Brand Name: BD FACSCALIBUR¿ FLOW CYTOMETER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: 13663604
• Report Number: 2916837-2022-00046
• Device Sequence Number: 1944174
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K923790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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
• Operator of Device: Other
• Device Model Number: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown