• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿ FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 342975
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  malfunction  
Event Description
It was reported that bd facscalibur¿ flow cytometer was leaking outside of the instrument.There was no report of patient impact.The following information was provided by the initial reporter.Instrument leaking.Leak checklist: 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? 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
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H.6 investigation summary: investigation summary: ¿ scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, serial # (b)(6).¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 13jun2021 to 13jun2022.¿ complaint trend: there were 3 complaints related to waste leakages due to clogged tubings; pr# (b)(4).Date range from 13jun2021 to 13jun2022.¿ manufacturing device history record (dhr) review: dhr part #342975 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 waste leakage not contained within the instrument was due to a clogged dcm (droplet containment module) line.This line is used to help aspirate waste to the waste tank, but any clogs or debris will contribute to leaks or backflow.The fse found that the leakage was due to a clogged section of the dcm tubing (pn 343585) and replaced the tubing.After the repair the instrument was tested and was performing as expected with no further leaks.No parts were requested for evaluation as the replaced part is not returnable and was discarded.Additionally, the leakage was not in the form of a spray and thus did not significantly increase the risk of exposure.Even though patient samples were used for clinical use, no patient was treated nor harmed from any erroneous results.The results were captured prior to any diagnosis decision and no report of delay in patient treatment.Proper daily and monthly cleaning and maintenance can help in maintaining an optimal system, and 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 #: (b)(4), case # (b)(4) install date: (b)(6) 2008 defective part number: 343585 work order notes: o subject / reported: instrument leaking o problem description: instrument leaking o work performed: replaced the clogged section of tubing (nsi pn 343585.) verified operation of the dcm.O cause: sip is dripping due to clogged dcm tubing between the flowcell and the dcm pump.O solution: the reported leak was resolved by replacing the clogged section of dcm tubing.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 the replaced part is not returnable and was discarded.¿ 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 o item: droplet containment module o function: to contain droplets o potential failure mode: droplets not contained o potential effects of failure: all of the sample is o potential causes/mechanisms of failure: pump not properly sealed o current controls: n/a o recommended actions: n/a o responsible party: n/a o target completion date: n/a o actions taken: n/a o sev: (b)(4) o occ: (b)(4) o det: (b)(4) o rpn: (b)(4) 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 clogged dcm line.¿ conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a clogged dcm line.The fse confirmed the issue and replaced the clogged section of the tubing (pn 343585).After the repair, the instrument was rebooted, tested, and 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.¿ supporting document: n/a.
 
Event Description
It was reported that bd facscalibur¿ flow cytometer was leaking outside of the instrument.There was no report of patient impact.The following information was provided by the initial reporter.Instrument leaking.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD FACSCALIBUR¿ FLOW CYTOMETER
Type of Device
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 Key14832632
MDR Text Key297767251
Report Number2916837-2022-00162
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903429752
UDI-Public00382903429752
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/23/2022
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
Device Operator Other
Device Model Number342975
Device Catalogue Number342975
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/13/2022
Initial Date FDA Received06/27/2022
Supplement Dates Manufacturer Received09/23/2022
Supplement Dates FDA Received09/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-