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

Model Number 338960

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd facscanto¿ ii flow cytometer was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: " was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained (if not contained) was there spray of fluid under pressure? no.What was the fluid that leaked? biohazard.What is the source of leak ¿ before waste line or after waste line? before waste line.(if waste line) ¿ was waste mixed with bleach or decontaminate? no.Was the customer/bd personnel physically in contact with the fluid? no.Fluidic problem.".

Event Description

It was reported that bd facscanto¿ ii flow cytometer was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: "1.Was the leak liquid or air? liquid 2.Was the leak contained within the instrument? not contained 3.(if not contained) was there spray of fluid under pressure? no 4.What was the fluid that leaked? biohazard 5.What is the source of leak ¿ before waste line or after waste line? before waste line -5b (if waste line) ¿ was waste mixed with bleach or decontaminate? no 6.Was the customer/bd personnel physically in contact with the fluid? no fluidic problem".

Manufacturer Narrative

H6: investigation summary: ¿ scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4_2 system ivd, part # 338960, serial # (b)(6).¿ problem statement: customer reported a complaint on a leakage of biohazard not contained within the instrument.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 07dec2020 to date 07dec2021.¿ complaint trend: there are 12 complaints related to the issue of a waste leakage not contained within the instrument.Date range from 07dec2020 to date 07dec2021.¿ manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(6), file # 338961-v96101005-900191457-09, 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 biohazard leak not contained within the instrument was due to a clog in the sample arm tubing and a loose flowcell.The customer had initially reported the fluidic issue and requested for a preventative maintenance.An fse (field service engineer) came onsite to inspect the issue, and was able to confirm the leakage.The fse found that the sample arm didn¿t aspirate liquid out of the sip and cleared the clog within it by backflushing the sample arm with hot water.They then noticed that the flowcell had moved out of position and realigned it with the fiber bundle as well as aligned the lasers.No parts were requested for evaluation as there were no replaced parts.After the repair, the instrument was tested with cv, baseline and performance tests which all passed.The instrument was functioning as expected with no further leakages.Although the leakage was of a biohazardous material, the customer confirmed that they did not come in contact with the leakage 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 can help in preventing lowered performance of the system, and can be found in the bd facscanto ii instructions for use (ifu), #23-20269-00 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 #: 02260833, case # 01529125 install date: 01jan2014 defective part number: n/a work order notes: o subject / reported: fluidic problem o problem description: sample arm overflow + no signal on all parameters o work performed: perform sit backflush, backflush work fine but sample arm doesn't aspirate liquid out of sip.Backflush sample arm with hot water, test sit flush, ok.Run beads, no signal on all channel, inspect flowcell
=
move.Re-align flowcell with fiber bundle, align all laser, cv good.Run cst baseline and performance, pass.Beads: nile red: pn.347240, lot# 2151215-03, exp: 2022-03-31.Blue beads: pn.347241, lot# a773507-04, exp: 2022-02-28.Yg : pn.91-0078, lot# 0154961, exp: 2022-06-30.Tools: no calibrated tools used o cause: sample arm clog + flowcell have move o solution: backflush sample arm + align flowcell, ok ¿ returned sample evaluation: a return sample was not requested because there were no replaced parts.¿ risk analysis: risk management file facscanto ii flow cytometer (fluidics) #338960-04ra (version a/revision 1) was reviewed and identified the hazard of a biohazard leakage.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? ¿yes ¿no o item: 12.Sample introduction tube o function: 12.1 retain tube until manually removed o potential failure mode: 12.1.1 tube pops off o potential effects of failure: 12.1.1.1 biohazard spill o potential causes/mechanisms of failure: 12.1.1.1.1 tube seated improperly, tube pressure set too high, or old bal seal does not seal adequately o current controls: user observation o recommended actions: 1.Lower pressure when not acquiring.2.Service provides spare bal seal to customer, and instructions to replace when any pressure loss is observed o responsible party: david vrane o target completion date: 5/1/2006 o actions taken: 1.Refer to canto ii sample load and unload workflow document, in clearcase2.Bd facscanto ii ifu (640773) - chapter 11; bd facscanto ii flow cytometer reference manual (640806) - chapter 4 o sev: 9 o occ: 4 o det: 2 o rpn: 72 o item: 22.Flow cell o function: 22.1 contain fluids o potential failure mode: 22.1.1 leaks sheath o potential effects of failure: 22.1.1.1 degrades gel, causes signal degradation or loss o potential causes/mechanisms of failure: 22.1.1.1.1 nozzle leak o current controls: 1.Manufacturing test for leaks (p/n 336782, facscanto flow cell assembly oms)2.New (since calibur) design with press fit (p/n 336977 assembly housing sample i/o.125 dia sit [note: pressed at vendor]) o recommended actions: n/a o responsible party: n/a o target completion date: n/a o actions taken: n/a o initial sev: 5 o initial occ: 5 o initial det: 1 o rpn: 25 mitigation(s) sufficient ¿yes ¿no ¿ root cause: based on the investigation results the root cause of the leakage of biohazard not contained within the instrument was due to a clogged sample line and loose flowcell.¿ conclusion: based on the investigation results the root cause of the leakage of biohazard not contained within the instrument was due to a clogged sample line and loose flowcell.The fse confirmed the issues and back flushed the sample line with hot water to clear the clog.They then realigned the flowcell with the fiber bundle and realigned the lasers.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical treatment was performed due to the biohazardous leak.The safety risk of this hazard has been identified to be within the acceptable level.H3 other text : see h10.

• Brand Name: BD FACSCANTO¿ II 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 Key: 13119636
• MDR Text Key: 286254507
• Report Number: 2916837-2021-00512
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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