MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD; COUNTER, DIFFERENTIAL CELL

Model Number 338960

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.(b)(6).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 running bd facscanto ii cytometer 4/2 system ivd waste leaked.There was no user impact.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? no.3.Was there spray of liquid under pressure? no.4.What was the fluid that leaked? waste.5.Did biohazard leak before or after waste line? after 6.Was the waste mixed with decontamination/bleach? no.7.Was the customer/bd personnel physically in contact with the fluid? no.8.Where did the physical contact of fluid occur? na.9.What personal protective equipment(ppe) was being used during the occurence? na.10.Was there any impact to patient samples due to leak? na.11.Was customer /bd personnel harmed/injured? no.12.What is the current medical status? na.On (b)(6) 2021 from task: in event description it was mentioned like "the plastic connector on the waste container, where the waste hose is attached, was leaking and broke off today " no leakage.On (b)(6) 2021 from task: in the entry description two issues are mentioned " leaking and broke off today" are they series of events or separate failure modes.06 sep 2021 additional information is needed to help determine reportability.The event description comments on dripping liquids.1.Was there a fluid leak? unknown.2.Was it contained within the instrument ? no.3.Was it biohazardous or non biohazardous ? if so, than biohazardous.4.Was anyone harmed for injured by any fluids leaked ? no.Customer's email: dear sirs and madames, in our canto v96100428, the plastic connector on the waste container, where the waste hose is attached, was leaking and broke off today.We swapped the slot for the hose (with the other short hose end piece) and closed the broken opening with parafilm.That's how it works again.But it would probably be better to replace the entire waste attachment.An attachment that is still present appears to be defective, as a full waste container is displayed continuously.

Event Description

It was reported that while running bd facscanto ii cytometer 4/2 system ivd waste leaked.There was no user impact.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? no 3.Was there spray of liquid under pressure? no 4.What was the fluid that leaked? waste 5.Did biohazard leak before or after waste line? after 6.Was the waste mixed with decontamination/bleach? no 7.Was the customer/bd personnel physically in contact with the fluid? no 8.Where did the physical contact of fluid occur? na 9.What personal protective equipment(ppe) was being used during the occurance? na 10.Was there any impact to patient samples due to leak? na 11.Was customer /bd personnel harmed/injured? no 12.What is the current medical status? na --------------------------------------------------- 06 oct 2021 from task: in event description it was mentioned like "the plastic connector on the waste container, where the waste hose is attached, was leaking and broke off today " no leakage ********************************** 06 oct 2021 from task: in the entry description two issues are mentioned " leaking and broke off today" are they series of events or separate failure modes.******************************* 06 sep 2021 additional information is needed to help determine reportability.The event description comments on dripping liquids.1.Was there a fluid leak? unknown 2.Was it contained within the instrument ? no 3.Was it biohazardous or non biohazardous ? if so, than biohazardous 4.Was anyone harmed for injured by any fluids leaked ? no customer's email: dear sirs and madames, in our canto v96100428, the plastic connector on the waste container, where the waste hose is attached, was leaking and broke off today.We swapped the slot for the hose (with the other short hose end piece) and closed the broken opening with parafilm.That's how it works again.But it would probably be better to replace the entire waste attachment.An attachment that is still present appears to be defective, as a full waste container is displayed continuously.

Manufacturer Narrative

H6: investigation summary: scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 sys ivd, part # 338960, serial # (b)(6).Problem statement: customer reported a complaint regarding a waste leakage not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 21jul2020 to date 21jul2021.Complaint trend: there are 2 complaints related to the issue of broken waste sensors causing a waste leakage not contained within the instrument.Date range from 21jul2020 to date 21jul2021.Manufacturing device history record (dhr) review: dhr part # 338960 serial # v96100428, file #338961-v96100428-900123584-07, 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 broken waste level sensor.A non-functioning waste sensor will not detect when the tank is full and can lead to a leak or spill.The customer had initially reported that the plastic connector on the waste container had leaked and broke off, causing the leakage.The tsr (technical service representative) confirmed the issue with the customer and shipped over part 338978 - snsr 2-level-sw 120vac 10.6in stem 7-pin as requested.When the part arrived, the customer was able to properly install the new waste level sensor and reported that after the repair, the instrument was functioning as expected with no further leakages.No parts were requested for evaluation as the replaced part is not returnable and was discarded.Although a leakage of waste poses a risk of harm to the customer upon skin contact, they customer confirmed that they did not come in direct contact with the leaked fluid and were not harmed in any way.Additionally, there was no spray of fluid so the risk of exposure was minimal.While this incident occurred on an instrument used for clinical diagnoses, the results gathered during the incident were not used for treatment and thus no patients were affected in any way.The safety risk is limited, s2, and there was no impact to customer health or safety.Service max review: review of related work order #: 02032112, case # 01406342 install date: 17jan2008 defective part number: 338978 - snsr 2-level-sw 120vac 10.6in stem 7-pin work order notes: o subject / reported: 338960 - bd facscanto ii cytometer 4/2 system ivd - damaged waste level sensor o problem description: in our canto v96100428, the plastic connector on the waste container, where the waste hose is attached, was leaking and broke off today.We swapped the slot for the hose (with the other short hose end piece) and closed the broken opening with parafilm.That's how it works again.But it would probably be better to replace the entire waste attachment.An attachment that is still there appears to be defective, as a full waste container is displayed continuously.Is it possible to get a replacement? o work performed: the customer received and installed a new level sensor.The device is working properly.O cause: wfc fr morgenroth sensor o solution: n/a 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 #338960-04ra, version a, bd facscanto ii flow cytometer (fluidics) fmea was reviewed.The severity rating in this file is ¿9¿ and the rpn is ¿18¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, whereby the biohazard exposure is obvious or indicated by additional (warning) information and hence the impact to the customer is negligible to none.The current mitigations are adequate with rpn under acceptable range.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? ¿yes ¿no o item: 6.Waste o function: 6.1 contain waste o potential failure mode: 6.1.1 waste not contained.O potential effect(s) of failure: 6.1.1.1 biohazards o potential cause(s) / mechanism(s) of failure: 6.1.1.1.2 waste container overflows.O current controls: level sensor.O recommended actions: n/a o responsible party: n/a o target completion date: n/a o actions taken: n/a o sev: 9 o occ: 2 o det: 1 o rpn: 18 mitigation(s) sufficient ¿yes ¿no root cause: based on the investigation results the root cause of the leakage not contained within the instrument was due to a broken waste level sensor.Conclusion: based on the investigation results the root cause of the leakage not contained within the instrument was due to a broken waste level sensor.The tsr confirmed the issue and sent a replacement to the customer.When the part arrived, the customer was able to properly install the part and they confirmed that the instrument was functioning as expected with no further leakages.No one was harmed or injured, and no medical treatment was performed due to the biohazardous leak.The safety risk is limited, s2, and there was no impact to customer health or safety.H3 other text : see h10.

• Brand Name: BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12665830
• MDR Text Key: 281275508
• Report Number: 2916837-2021-00403
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

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 Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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