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 10/25/2021

Event Type  malfunction  

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 user impact.The following information was provided by the initial reporter, translated from (b)(6) to english: liquid leaks from the right side of the main unit, please confirm the safety check below.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.

Event Description

It was reported that while using bd facscanto¿ ii flow cytometer biohazardous waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter, translated from japanese to english: liquid leaks from the right side of the main unit please confirm the safety check below.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.

Manufacturer Narrative

H6: 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 complaint on a leakage of biohazard fluid not contained with instrument manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 26oct2020 to date 26oct2021.Complaint trend: there are 12 complaints related to the issue of biohazard leakages not contained within the instrument.Date range from 26oct2020 to date 26oct2021.Manufacturing device history record (dhr) review: dhr part # 338960 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 biohazard leak not contained within the instrument was due to a worn restrictor.The customer had initially reported that there was a liquid leakage from the right side of the instrument.The fse (field service engineer) responding to the issue confirmed the leakage to be due to a worn restrictor and replaced the part (pn 339294).The fse also found that the compressor was taking abnormally long to pressurize and recommended that the customer replace it.After the repair, the instrument was performing as expected with no further leaks.No parts were requested for evaluation as the restrictor is not returnable and was discarded.Although the leakage of waste poses the risk of contamination upon contact, the customer confirmed that they did not come in contact with the fluid and were not harmed in any way.Additionally, there was no spray of fluid outside of the instrument and thus no increased risk of exposure.The instrument was being used for clinical diagnoses but the incident did not delay or otherwise affect the treatment of any patients.The safety risk is limited, s2, and there was no impact to customer health or safety.Service max review: review of related work order #: 02208199, case # (b)(4) install date: 29sep2006 defective part number: 339294 - restrictor inline.010in id 1/16 tube yel work order notes: o subject / reported: liquid leaks from the right side of the main unit o problem description: liquid leaks from the right side of the main unit o work performed: i have confirmed the symptoms.We have confirmed a liquid leak from the restrictor on the side of the cytmeter.We have replaced the restrictor.At the same time, case (01510690) was carried out.Diva software ver has been updated from 5.0.1 to 6.1.3.We have confirmed the operation with ur beads.As a result, it was confirmed that it took too long to pressurize the compressor.It is recommended to replace the compressor because the compressor pressure is about 85psi.No business trip fee will be charged due to the previous rework.O cause: liquid leaks from the right side of the main unit o solution: i have confirmed the symptoms.We have confirmed a liquid leak from the restrictor on the side of the cytmeter.We have replaced the restrictor.At the same time, case (01510690) was carried out.Diva software ver has been updated from 5.0.1 to 6.1.3.We have confirmed the operation with ur beads.As a result, it was confirmed that it took too long to pressurize the compressor.It is recommended to replace the compressor because the compressor pressure is about 85psi.No business trip fee will be charged due to the previous rework.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¿ 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 worn waste restrictor.Conclusion: based on the investigation results the root cause of the leakage not contained within the instrument was due worn waste restrictor.The fse confirmed the issue and identified the leakage to be from the restrictor.The fse also recommended the customer to replace the compressor since it took longer than expected to pressurize.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 is limited, s2, 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13097395
• MDR Text Key: 283485913
• Report Number: 2916837-2021-00504
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: 01/14/2022
• 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