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

Model Number 338962

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/09/2023

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 while using the bd facscanto¿ ii that there was a waste leakage without bleach not contained (outside instrument).The following information was provided by the initial reporter.In a telephone conversation with the user, it was established that the leak came from the truck.Most likely a waste line.The client is not able to move the stroller by herself and take a more accurate picture.Pictures sent in attachment.Other symptoms are low fluid in the beaker.The client noticed that in the diva system, the status of the coil container was neither green nor red (i.E.Neither empty nor full) but everything was black, so she decided to empty the tank and then noticed the leak.The client was informed about the need to disconnect the wheelchair from the power source.Description of the failure: leaks from the hose on the left side at the bottom.I asked the client for more precise information.They will be sent.

Manufacturer Narrative

H.6 investigation summary scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2/2 sys ivd, part # 338962 and serial # (b)(6).Problem statement: customer reported complaint regarding a leak on 09jan2023.This poses the risk of harming or injuring the customer or patient due to contact with the fluid.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 10jan2022 to 10jan2023.Device history record (dhr) review: dhr part # 338962 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 430 complaints related to as reported code 1 : fluidic ¿ leak.Then further filtered by as analyzed code 1, as analyzed code 2 and as analyzed component there are 49 complaints.Date range from 10jan2022 to 10jan2023.The complaint history report is attached to trackwise.Returned sample analysis: a return sample was not requested because parts replaced are not returnable.Service history review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2014.Defective part number: 59-10092-02s, 343527, 336978, 33697707, 59-10181-05, 59-10090-05.Work order notes: o subject / reported: (b)(6) - bd facscanto ii cytometer 4/2/2 sys ivd - leak.O problem description: fault description: leaks from the hose on the left side at the bottom.- i asked the client for more accurate information.They will be sent.O work performed: on 2023.02.07.Leak, on a trolley with liquids observed inside probably from several fittings and hoses.Due to the time limit, the problem has not been completely solved, it is necessary to order additional spare parts and visit again from the morning.On 2023.02.13 replacement of fittings of 1 pcs p/n: 59-10092-02s, 343527, 336978, 33697707.Replacement of fittings 2 pcs.P/n: 59-10181-05, 59-10090-05.After the replacement, no leaks were observed cleaning and tuning of optics, control of system operation with cab beads.Cs&t-result check performed.Technically efficient system, periodic inspection recommended.O cause: defective fluid module.O solution: performance control.O parts replaced: 59-10092-02s, 343527, 336978, 33697707, 59-10181-05, 59-10090-05.Labeling / packaging review: n/a.Risk analysis: risk management file part # 338942ra, rev.09/vers.H, ra bd facscanto product family was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.O id: (b)(4).O hazard : potential leakage.O cause: potential lack of workmanship during assembly.O harmful effects: potential biohazard exposure.O residual probability: 1.O residual severity: 4.O residual risk index: 4.Potential causes: based on the investigation results, the potential cause was determined to be a defective fluid module.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause of the leak was a defective fluid module.The customer reported a complaint regarding a leak from the hose on the left side.The field service representative (fsr) confirmed that there was leakage on the fluid cart and proceeded to replace the fittings and connectors ¿ pn 59-10092-02s, 343527, 336978, 33697707, 59-10181-05, 59-10090-05.The fsr also cleaned and tuned the optics and verified the system operation with cab beads.After the replacement, the instrument was tested and was performing as intended.Although the leak was waste and there was potential for exposure to biohazard material, there was no skin contact nor was there any medical treatment performed.No user was harmed or injured.Cleaning the fluidics and regular maintenance is essential for keeping the instrument at its optimal performance.Bd facscanto ii instructions for use (ifu), #23-20269-00 rev.1/vers.A, indicates to wear suitable protective clothing and gloves to prevent transmission of potential fatal disease from biological specimens.This can be found on page 147 in cleaning the surfaces.The safety risk of this hazard has been identified to be within the acceptable level.Conclusion: based on the investigation results, complaint was confirmed and the potential cause of the leak was a defective fluid module.The customer reported a complaint regarding a leak from the hose on the left side.The fsr confirmed that there was leakage on the fluid cart and proceeded to replace the fittings and connectors.After the replacement, the instrument was tested and was performing as intended.No user was harmed or injured.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.Supporting document.

Event Description

It was reported that while using the bd facscanto¿ ii that there was a waste leakage without bleach not contained (outside instrument).The following information was provided by the initial reporter.In a telephone conversation with the user, it was established that the leak came from the truck.Most likely a waste line.The client is not able to move the stroller by herself and take a more accurate picture.Pictures sent in attachment.Other symptoms are low fluid in the beaker.The client noticed that in the diva system, the status of the coil container was neither green nor red (i.E.Neither empty nor full) but everything was black, so she decided to empty the tank and then noticed the leak.The client was informed about the need to disconnect the wheelchair from the power source.Description of the failure: leaks from the hose on the left side at the bottom.I asked the client for more precise information.They will be sent.

• Brand Name: BD FACSCANTO¿ II
• 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: 16272559
• MDR Text Key: 308859024
• Report Number: 2916837-2023-00021
• Device Sequence Number: 1
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: 00382903389629
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K141468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338962
• Device Catalogue Number: 338962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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