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 06/24/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facscanto ii cytometer 4/2 system ivd waste leakage without bleach not contained (outside instrument).The following information was provided by the initial reporter: 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 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 cytometer 4/2 system ivd waste leakage without bleach not contained (outside instrument) the following information was provided by the initial reporter: 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

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 waste leakage not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 24jun2021 to 24jun2022.Complaint trend: this is the only complaint related to the issue of waste leakage not contained within the instrument due to worn tubing for part # 338960.(b)(4).Date range from 24jun2021 to 24jun2022.Manufacturing device history record (dhr) review: dhr part # 338960, serial # (b)(6), file #338961-v96101246-900230482-10 was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed based on a review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, and the root cause of the waste leakage not contained within the instrument was a worn liquid feed pump tube in the fluidics cart.As part of a routine pm (preventative maintenance) work order (b)(4), the fse (field service engineer) identified the leakage issue and replaced the tubing (part # 335664 - tubing tygon 1/8id x 1/4odx 1/16wall) alongside performing standard pm tasks like replacing pm kits and cleaning the flow cells.After the repair, the instrument was 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 fluidic waste and there was a potential of exposure to biohazardous material, there was no skin contact, and 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 potentially 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 #: (b)(4), case # (b)(4) install date: 31mar2010 defective part number: 335664 - tubing tygon 1/8id x 1/4odx 1/16wall case comments: on (6/24/2022 4:44 am) coview kusuda discovered during another work.Former wo: (b)(4).Leakage from cart.It has been dealt with by exchanging the tube on site.No health hazard on (6/24/2022 1:24 am) leakage from cart work order notes: subject / reported: periodic inspection problem description: periodic inspection work work performed: "periodical inspection work before inspection work, check various data replacement of consumable parts (pm kit, etc.) washed with flowcell 50% diluted contrad 70 performance and operation check of each part based on inspection and maintenance report cleaning the optical part adjusting the optical axis cart circuit voltage adjustment long clean implementation 1: there is a leak in the cart deterioration of liquid feed pump tube, replaced¿ ¿· hts operation check normal · check cv% value with ultrarainbow beads · cst implementation (baseline & check performance)¿ all pass 1: confirm that there is no liquid leakage in the cart until the inspection is completed.¿ solution: "·hts operation check normal check cv% value with ultrarainbow beads cst implementation (baseline & check performance)¿all pass 1: confirm that there is no liquid leakage in the cart until the inspection is completed.¿ 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, rev.01/vers.A, bd facscanto ii flow cytometer (fluidics) fmea (failure mode and effect analysis) was reviewed.No new hazards have been identified and the current mitigations are sufficient with rpn within an acceptable range.Hazard(s) identified? yes/no item: 4.Quick disconnect function: 4.1 connects tubing to filters and fluid tanks.Potential failure mode: 4.1.1 tubing failure potential effect(s) of failure: 4.1.1.1 leaks at waste tank.Biohazard.Potential cause(s) / mechanism(s) of failure: waste fitting leaks current controls: 1.Pump compensates for leaking.Initial sev: 9 initial occ: 6 initial det: 1 final rpn: 0 mitigation(s) sufficient yes/no root cause: based on the investigation results, the root cause was a worn liquid feed pump tube.Conclusion: based on the investigation results, the root cause of waste leaking outside the facscanto ii was a worn liquid feed pump tube.As part of a routine pm work order, the fse identified the leakage issue and replaced the tubing (part # 335664 - tubing tygon 1/8id x 1/4odx 1/16wall).After the repair, the instrument was found to be functioning as expected.No one was harmed or injured due to the biohazardous leak.The safety risk of this hazard has been identified to be within the acceptable level.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14935968
• MDR Text Key: 297488883
• Report Number: 2916837-2022-00174
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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: 10/14/2022
• 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