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

Model Number 338960

Device Problem Leak/Splash (1354)

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

Event Date 09/05/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer that there is a bad waist level sensor.The following information was provided by the initial reporter that at the time of inspection, there was a leak from the base of the waist level sensor tube, so i replaced it.Fse replaced the waste level sensor, and after that, the issue was resolved.It was confirmed that the instrument worked normally.Was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was there spray of fluid under pressure? 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 or 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: 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 regarding a leak at the base of the waste level sensor tube.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue for part # 338960.Date range from 06sep2021 to 06sep2022.Complaint trend: there are 5 complaints related to a fluidic leak caused by an electrical problem for part # 338960.Pr# (b)(4), date range from 06sep2021 to 06sep2022.Manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(6), file #338960-v96101212-900223195-10 and 338961-v96101212-900223194-09 were 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 leak was a deteriorated waste level sensor.A non-functioning waste sensor will not detect when the tank is full and can lead to a leak or spill.As part of a routine pm (preventative maintenance) visit (wo-02590810), the fse (field service engineer) identified a leak at the base of the waste level sensor tube during inspection and confirmed it was due to a worn out waste level sensor.The fse replaced the waste level sensor (part # 338978 - snsr 2-level-sw 120vac 10.6in stem 7-pin) and tested the instrument.After the repair, the instrument was found to be performing as expected with no further leaks.The part was not requested for evaluation because it is not returnable and was discarded.Although the leak was biohazardous waste, there was no physical contact nor was any medical treatment performed.No user was harmed or injured.Bd facscanto ii instructions for use (ifu), #23-20269-00 rev.01/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.Service max review: review of related work order #: 02590810, case # (b)(4).Install date: (b)(6) 2010.Defective part number: 338978 - snsr 2-level-sw 120vac 10.6in stem 7-pin.Case comments: ((b)(6) 2022 10:01 pm) bad waist level sensor.((b)(6) 2022 10:05 pm) there was a leak at the base of the waist level sensor tube during inspection.So i replaced it.(corrected by wo-02590810).Work order notes: work performed: (treatment)·pre-inspection data confirmation (ur beads)· replacement of expendable parts (filter, coupling)· fluid system cleaning, optical system cleaning work·waist level sensor replacement (due to deterioration)·check data after inspection (ur beads)·cst baseline, check performance test.We have completed the inspection work.Cause: n/a.Solution: performed inspection work and confirmed normal operation.Returned sample evaluation: a return sample was not requested for evaluation because the replaced part is not returnable and was discarded.Risk analysis: risk management file part #338960-04ra, rev.01/vers.A, bd facscanto ii flow cytometer (fluidics) fmea (failure mode and effects analysis) was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified?: yes or no? id: 6.Waste.Potential failure mode (hazard): 6.1.1 waste not contained.Potential effect(s) of failure (harmful effects): 6.1.1.1 biohazards.Potential cause(s)/mechanism(s) of failure (cause): 6.1.1.1.2 waste container overflows.Residual severity: 9.Residual probability (occurrence): 2.Residual rpn (risk index): 18.Root cause: based on the investigation results, the root cause was a deteriorated waste level sensor.Conclusion: based on the investigation results, the root cause of waste leaking outside the facscanto ii was a deteriorated waste level sensor.The fse identified the leak and cause during a routine pm inspection, and replaced the waste level sensor (part # 338978 - snsr 2-level-sw 120vac 10.6in stem 7-pin).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.Supporting document: n/a.

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer that there is a bad waist level sensor.The following information was provided by the initial reporter that at the time of inspection, there was a leak from the base of the waist level sensor tube, so i replaced it.Fse replaced the waste level sensor, and after that, the issue was resolved.It was confirmed that the instrument worked normally.1.Was the leak fluid or air? fluid.2.Was the leak contained within the instrument? no.3.Was there spray of fluid under pressure? no.4.What was the fluid that leaked? biohazard.5.Did biohazard leak before or after waste line? after waste line.6.Was the waste mixed with decontamination or bleach? no.7.Was the customer/bd personnel physically in contact with the fluid? no.

• 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: 15451489
• MDR Text Key: 306421009
• Report Number: 2916837-2022-00259
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: (01)00382903389605
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062087
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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: 12/22/2022
• 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