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

Catalog Number 343202

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/15/2021

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 facscalibur¿ was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: "customer reports that the instrument did not empty the intermediate waste container and the liquid came out from the venting line causing a leakage on the floor.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? after waste line.Was the waste mixed with decontamination/bleach? no.Was the customer/bd personnel physically in contact with the fluid? physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin: no".

Manufacturer Narrative

H.6.Investigation: ¿ scope of issue: the scope of issue is only limited to facscalibur 4 clr basic sensor unit, part # 343202, serial # (b)(6).¿ problem statement: customer reported complaint of leakage of biohazard not contained within instrument.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 15dec2020 to 15dec2021.¿ complaint trend: there are (b)(4) complaints related to the issue of backflow leaking outside of the instrument.Date range from 15dec2020 to 15dec2021.¿ manufacturing device history record (dhr) review: dhr part #343202 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 was due to a dirty ffss waste probe.This waste probe is responsible for detecting if the waste intermediate tank is full, and lowered performance of this probe can lead to the tank overfilling and consequently spilling.The customer had initially reported that the instrument did not empty the intermediate waste container and caused a leakage from the vent line.A remote assistance was scheduled with a tsr (technical service representative) who identified the issue and asked the customer to clean the ffss waste probe and test it with water.After the cleaning, the instrument was tested and confirmed to be functioning as expected.No parts were requested for evaluation as there were no parts replaced.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 instructions on these procedures can be found in the bd facscalibur system user¿s guide, #338183 rev.1/vers.A.The safety risk of this hazard will be evaluated in ecr (b)(4).¿ service max review: review of related work order #: (b)(4) , case # (b)(4), install date: 28feb2012, work order notes: o subject / reported: 343202 - facscalibur - leakage from the waste intermediate container.O problem description: customer reports that the instrument did not empty the intermediate waste container and the liquid came out from the venting line causing a leakage on the floor.O work performed: cleaned and dried ffss waste probe.O cause: waste probe did not detect that the waste intermediate tank was full o solution: the instrument is working within specs.¿ returned sample evaluation: a return sample was not requested because there were no replaced parts.¿ risk analysis: risk management file part # (b)(4), rev.04/vers.D, risk analysis facscalibur prod family was reviewed.This file did not contain the appropriate hazards and mitigations, and an eco has been opened to assess additional hazards and their risk levels.Ecr #(b)(4), has been created and will revise the existing calibur risk analysis document to include causes, mitigations, and risk ratings for carryover, erroneous results, and waste exposure.¿ root cause: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a dirty waste probe.¿ conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a dirty waste probe.During the remote consultation with a tsr, the customer cleaned and dried the ffss waste probe.After the cleaning, the instrument was tested and reported to be functioning as expected.No one was harmed or injured, and no further leaks occurred.The safety risk of this hazard will be evaluated in ecr (b)(4).H3 other text : see h.10.

Event Description

It was reported that bd facscalibur¿ was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: "customer reports that the instrument did not empty the intermediate waste container and the liquid came out from the venting line causing a leakage on the floor.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?: after waste line.Was the waste mixed with decontamination/bleach?: no.Was the customer/bd personnel physically in contact with the fluid?: physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no".

• Brand Name: BD FACSCALIBUR¿
• 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: 13119629
• MDR Text Key: 283955706
• Report Number: 2916837-2021-00511
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K973483
• 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: 05/23/2022

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 Catalogue Number: 343202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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