MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD; COUNTER, DIFFERENTIAL CELL

Model Number 342975

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/01/2021

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 facscalibur cytometer 4 color basic ivd leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: 1.Was the leak fluid or air? (if fluid, go to question #2.If air, no further questions required.) liquid.2.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.) not contained.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) bio hazard.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) before waste line.6.Was the waste mixed with decontamination or bleach? (if no, go to question #7.If mixed with decontamination, no further questions required.) 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.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin." (b)(4): 2021-09-01 10:20:38 (gmt) if the sit arm is put aside, the dcm pump no longer starts and there is no longer any suction.The measurements still work without any problems.

Event Description

It was reported that while using facscalibur cytometer 4 color basic ivd leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: 1.Was the leak fluid or air? (if fluid, go to question #2.If air, no further questions required.) liquid.2.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.) not contained.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).Bio hazard.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).Before waste line.6.Was the waste mixed with decontamination or bleach? (if no, go to question #7.If mixed with decontamination, no further questions required.) 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.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin." (b)(6) 2021 10:20:38 (gmt): if the sit arm is put aside, the dcm pump no longer starts and there is no longer any suction.The measurements still work without any problems.

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, serial #(b)(4).Problem statement: customer reported complaint of 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 01sep2020 to date 01sep2021.Complaint trend: there are 4 complaints related to a biohazard leakage not contained within the instrument; date range from 01sep2020 to date 01sep2021.Manufacturing device history record (dhr) review: dhr part #342975 serial # (b)(6), file #342975-e97500128-900062276-06, 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 waste leakage was due to a worn pressure switch.The customer reported that the dcm pump would not aspirate the liquid coming from the sit, though the instrument would measure the sample as usual.The fse (field service engineer) responding to the issue confirmed that the dcm pump was functioning and the voltage of the dcm module and resistance of the aspirator arm controller were within expectations.They then found that replacing the pressure switch (pn 349532) allowed the dcm to run again and the sit no longer leaked.No parts were requested for evaluation as the replaced part is not returnable and was discarded.After the repair the instrument was tested and was performing as expected with no further leaks.Although there was a leakage of biohazard which can pose a risk of contamination upon skin contact, the customer confirmed that they had not come in contact with the leakage and were not harmed in any way.Additionally, there was no spray of fluid, so there was no increased risk of exposure.Proper daily and monthly cleaning and other maintenance can help maintain a healthy fluidics system and identify risks before an incident.Details on these procedures and the proper use of the instrument can be found in the bd facscalibur¿ instructions for use, 23-12911-02 rev.1/vers.A.The safety risk is limited, s2, and there was no impact to customer health or safety.Service max review: review of related work order #: 02090059, case # 01440851 install date: 14jun2018 defective part number: 349532 - assy switch pressure 10psi work order notes: o subject / reported: 342975 - facscalibur cytometer 4 color basic ivd - defective dcm-pump o problem description: if the sit arm is set aside, the dcm pump no longer starts and there is no longer any suction.The measurements still work without any problems.O work performed: dcm pump, 660049, exchanged, problem still exists, exchanged back.Voltage measured on power supply of the dcm module, 12.41 v, ok.Resistance measured on aspirator arm controller, open: 0.1 ohm, ok.10psi pressure switch, 349532, exchanged, dcm pump runs again, needle no longer drips.Rainbow beads measured, cvs in the normal range, ok.The device works perfectly and was handed over to the customer ready for use.O cause: 10psi pressure switch, 349532, defect 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 # 342973-01ra, rev.01/vers.A, bd facscalibur failure mode and effect analysis was reviewed.The severity rating in this file is ¿5¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, whereby a waste leak is obvious or indicated by additional (warning) information and hence the impact to the patient is negligible to none.The current mitigations are adequate with rpn under acceptable range.Hazard(s) identified? ¿yes ¿no o item: droplet containment module o function: to contain droplets o potential failure mode: droplets not contained o potential effects of failure: all of the sample is o potential causes/mechanisms of failure: pump not properly sealed o current controls: n/a o recommended actions: n/a o responsible party: n/a o target completion date: n/a o actions taken: n/a o sev: 5 o occ: 5 o det: 1 o rpn: 25 mitigation(s) sufficient ¿yes ¿no root cause: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a worn pressure switch.Conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a worn pressure switch.The fse confirmed the issue and replaced the pressure switch.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no further leaks occurred.The safety risk is limited, s2, and there was no impact to customer health or safety.See h10.

• Brand Name: FACSCALIBUR CYTOMETER 4 COLOR BASIC 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: 12665879
• MDR Text Key: 284117867
• Report Number: 2916837-2021-00404
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• 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: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/20/2021
• 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