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 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone#: (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 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: details taken from smax check list: was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): unknown.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): unknown.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.): no.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.Task (b)(4) completed: what was the fluid that leaked? (biohazardous or non-biohazardous): biohazardous.If it is biohazard did biohazard leak before or after waste line? after the waste line (the tip the probe).

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: details taken from smax check list: was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): unknown.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): unknown.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.): no.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.Task 3720546 completed: ¿ what was the fluid that leaked? (biohazardous or non-biohazardous): biohazardous.¿ if it is biohazard did biohazard leak before or after waste line? after the waste line (the tip the probe).

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 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 15sep2020 to 15sep2021.Complaint trend: there are 11 complaints related to a waste leakage not contained within the instrument; date range from 15sep2020 to 15sep2021.Manufacturing device history record (dhr) review: dhr part #342975 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 waste leakage not contained within the instrument was due to a blocked peristaltic tubing, or pinch valve tubing.The pinch valve¿s default state is pinched shut, so if an instrument is unused for a prolonged amount of time this tubing will be worn, closed shut or not fully open and will have to either be exercised/massaged and reconnected or replaced entirely.¿blockage of this tube can commonly cause weakened aspiration of the sit and lead to dripping.The fse (field service engineer) confirmed the leakage, replaced the t fitting for the peristaltic pump, or pinch valve, output, and replaced the peristaltic pump tubing.No parts were requested for evaluation as the replaced parts are not returnable and were discarded.After the repair the instrument was tested and was performing as expected with no further leaks.Although the leakage of biohazardous material can cause harm to the customer from exposure to samples and chemicals, the customer was not harmed in any way as they had not come in contact with the leakage.Additionally, the leakage was not in the form of a spray and thus did not significantly increase the risk of exposure.Proper scheduled cleaning and other maintenance can help in reducing the possibility of blocked tubing, and instructions can be found in the bd facscalibur¿ instructions for use, 23-12911-02 rev.1/vers.A, starting on pages 60 and 173 (maintenance).The safety risk is limited, s2, and there was no impact to customer health or safety.Service max review: review of related work order #: 02110306, case # (b)(4) install date: 15mar2011 defective part number: 343585 - tubing neoprene dcm 59-10027-00s - fitting t 1/16 id service work order notes: subject / reported: probe drips.Problem description: probe drips.Work performed: replaced t fitting at peristaltic pump output.Replaced peristaltic pump tubing.Cause: blockage on peristaltic pump line.Solution: issue resolved.Returned sample evaluation: a return sample was not requested because there were no replaced parts.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 item: droplet containment module.Function: to contain droplets.Potential failure mode: droplets not contained.Potential effects of failure: all of the sample is.Potential causes/mechanisms of failure: pump not properly sealed.Current controls: n/a.Recommended actions: n/a.Responsible party: n/a.Target completion date: n/a.Actions taken: n/a.Sev: 5 occ: 5 det: 1 rpn: 25 mitigation(s) sufficient: yes no root cause: based on the investigation results the root cause of the leakage was due to a blockage in the pinch valve tubing.Conclusion: based on the investigation results the root cause of the leakage was due to a blockage in the pinch valve tubing.The fse confirmed the issue, replaced the pinch valve tubing and pinch valve tubing¿s t fitting, and the instrument was confirmed to be 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.

• 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: 12619335
• MDR Text Key: 276182590
• Report Number: 2916837-2021-00392
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: BC
• PMA/PMN Number: K923790
• 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: 01/10/2022

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
• Device Lot Number: E97501639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/13/2022
• 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