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 08/24/2021

Event Type  malfunction  

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer biohazardous waste leaked outside of instrument.There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: customer asks for advice on which spare parts can be changed to eliminate problems with the waste mechanism.Was the leak fluid or air? (if fluid, go to question #2.If air, no further questions required.) - fluid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.) - no.Was there spray of fluid under pressure? (if yes describe the fluid that sprayed then go to question #7, if no, go to question #4) - no.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard, go to question #5) - biohazrd.Did biohazard leak before or after waste line? (if before waste line, go to question #7.If after waste line, go to question #6) - after.Was the waste mixed with decontamination or bleach? (if no, go to question #7.If mixed with decontamination, no further questions required.) - no.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no contact, no further questions required.) ¿ no.

Manufacturer Narrative

Medical device expiration date: na.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 bd facscanto¿ ii flow cytometer biohazardous waste leaked outside of instrument.There was no patient impact.The following information was provided by the initial reporter, translated from german to english: customer asks for advice on which spare parts can be changed to eliminate problems with the waste mechanism.1.Was the leak fluid or air? (if fluid, go to question #2.If air, no further questions required.) - fluid 2.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.) - no.3.Was there spray of fluid under pressure? (if yes describe the fluid that sprayed then go to question #7, if no, go to question #4) - no.4.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard, go to question #5) - biohazrd.5.Did biohazard leak before or after waste line? (if before waste line, go to question #7.If after waste line, go to question #6) - after.6.Was the waste mixed with decontamination or bleach? (if no, go to question #7.If mixed with decontamination, no further questions required.) - no."7.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no contact, no further questions required.) ¿ no.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 system ivd, part # 338960, and serial # (b)(6) problem statement: customer reported a complaint regarding a leakage not contained within the instrument.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 24aug2020 to date (b)(6) 2021.(b)(6).Complaint trend: there are 8 complaints related to a biohazard leakage not contained within the instrument.Date range from 24aug2020 to date 24aug2021.Manufacturing device history record (dhr) review: dhr part #338960 serial # (b)(6) , file #338961-v96100517-900133225-07, 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 the biohazard leakage not contained within the instrument was due to worn waste tank components.The customer had initially submitted a complaint regarding a waste leakage as well as an inquiry on which components were needed to repair the instrument.A tsr (technical service representative) called the customer regarding the issue and was able to help them identify the broken waste tank cap (pn 338922) and baffle (pn 33850507) that needed to be replaced.The tsr then gave instructions on how to properly replace the parts and sent them over.When the customer received the parts, they installed the parts, tested the instrument, and confirmed that the instrument was functioning as expected with no further leakages.No parts were requested for evaluation as the replaced parts are not returnable and were discarded.Although the leakage of biohazard poses a risk of potential contamination upon skin contact, the customer confirmed that they did not come in direct contact with the leakage and were not harmed in any way.Additionally, the leakage was not in the form of a spray so the risk of contamination was minimal.The safety risk is moderate, s3, and there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4) , case # (b)(4).Install date: (b)(6) 2008 defective part number:.338922 - waste caps (2).33850507 - baffle spa 10l waste tank ext - service.Work order notes: o subject / reported: facscanto ii, pcn 338960, ic 34162, problem with waste mechanism o problem description: customer asks for advice on which spare parts can be changed to eliminate problems with the waste mechanism.O work performed: new cap (338922) and baffle (33850507).O cause: cap and baffle were destroyed.O solution: n/a.¿ returned sample evaluation: a return sample was not requested because the replaced parts are not returnable and were discarded.¿ risk analysis: risk management file part #¿338960-04ra, rev.01/vers.¿a,¿bd¿facscanto¿ii flow cytometer (fluidics) fmea¿was reviewed.No new hazards have been identified and the current mitigation¿is¿sufficient.¿ the severity rating in this file is ¿9¿ based on the previous scale rating.This is equivalent to ¿s3¿ in sop6078-02¿rev.12/vers.J, whereby the leakage 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.¿ hazard(s) identified? ¿yes ¿no.O item: 4.Quick disconnect.O function: 4.1 connects tubing to filters and fluid tanks.O potential failure mode: 4.1.1 tubing failure.O potential effect(s) of failure: 4.1.1.1 leaks at waste tank.Biohazard.O potential cause(s)/mechanism(s) of failure: waste fitting leaks.O current controls: 1.Pump compensates for leaking.O recommended actions: n/a.O severity:(b)(6) o occurrence: (b)(6) o detection: 1.O rpn: 54.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 worn waste tank components.¿ conclusion: based on the investigation results the root cause of the leakage not contained within the instrument was due to worn waste tank components.The customer had initially submitted the complaint about the waste leakage and an inquiry on the parts needed to fix the issue.During the phone consultation, the tsr helped the customer identify the broken cap and baffle that needed to be repaired.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is moderate, s3, and there was no impact to customer health or safety.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12790423
• MDR Text Key: 283830155
• Report Number: 2916837-2021-00435
• 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: 12/06/2021

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: 11/09/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/16/2021
• 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