MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿; COUNTER, DIFFERENTIAL CELL

Model Number	657338
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd facscanto¿ leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: "during the cleaning an error message pops up.It looks like the aspirator arm is not acquiring the liquid.The tube is getting wet on the top.Error message: vacuum error has been detected.Disconnecting and connecting the waste tank.Startup has been performed and it was ok.Removing the o-ring and the retainer, cleaning around and making sure that they are well set didn't help neither.They didn't use the instrument for more than two weeks.Maybe the waste line is clogged.There is no leak in this work order.If this is about ¿the tube is getting wet on the top".Is the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was the fluid actively spraying about outside the machine? no.Is leaked liquid type known? biohazardous or non-biohazardous? biohazardous.Did the leaked liquid have bleach mixed in? no.Was anyone injured due to the leaked liquid? no.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd facscanto¿ leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: "during the cleaning an error message pops up.It looks like the aspirator arm is not acquiring the liquid.The tube is getting wet on the top.Error message: vacuum error has been detected.Disconnecting and connecting the waste tank.Startup has been performed and it was ok.Removing the o-ring and the retainer, cleaning around and making sure that they are well set didn't help neither.They didn't use the instrument for more than two weeks.Maybe the waste line is clogged.There is no leak in this work order.If this is about ¿the tube is getting wet on the top¿ ¿ 1.Is the leak fluid or air? fluid 2.Was the leak contained within the instrument? no 3.Was the fluid actively spraying about outside the machine? no 4.Is leaked liquid type known? biohazardous or non-biohazardous? biohazardous 5.Did the leaked liquid have bleach mixed in? no 6.Was anyone injured due to the leaked liquid? no".
Additional Manufacturer Narrative
H.6 investigation summary: scope of issue: the scope of issue is only limited to facscanto ivd 10 part # 657338, serial # (b)(6).Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 03jun2021 to date 03jun2022.Complaint trend: there are 4 complaints similar to this one of leakage of biohazard; pr# (b)(4).Date range from 03jun2021 to date 03jun2022.Manufacturing device history record (dhr) review: dhr part # 657338, 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 a leak in the facscanto instrument was due to a blockage in the waste line.The user disconnected and connected the waste tank and performed startup.They removed the o-ring and the retainer, cleaned around and made sure that they were well set but this did not help resolve the issue.The technical support center specialist noted that the waste line must have been clogged.The fse confirmed the issue and cleared the tubing line by performing a flush to ensure proper flow and accuracy.No parts were requested for evaluation.After the repair the instrument was tested and was performing as expected.Although a leak was present, and no one was injured, users should wear proper ppe (personal protective equipment) while operating the instrument as stated in the bd facscanto¿ flow cytometer instructions for use (ifu), #23-14730-03 rev.1/vers.A, starting on page 147 in cleaning the surfaces.In addition, proper handling of fluidic filters can be found starting on page 149, maintenance.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: (b)(6) 2014 defective part number: n/a work order notes: o subject / reported: 657338 - facscanto ivd 10 - vacuum error has been detected o problem description: during the cleaning an error message pops up.It looks like the aspirator arm is not acquiring the liquid.The tube is getting wet on the top.Error message: vacuum error has been detected.O work performed: flushed the waste lines using syringe ok.Measured vacuum at the waste pump ok.Run beads for 30 min, no error message.The instrument is ready for use.O cause: blockage o solution: flushed the waste lines returned sample evaluation: a return sample was not requested because no parts replaced.Risk analysis: risk management file part # 338942ra (revision 08, version g) facscanto product family risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no o id: (b)(6) o hazard: potential leakage o cause: potential lack of workmanship during assembly o harmful effects: potential biohazard exposure o risk control: qualification and first article inspection o implementation verification: vp # 11392 protocol o effectiveness verification: vp # 11392 report o p: (b)(4) o s: (b)(4) o ri: (b)(4) o residual risk evaluation : afap o new hazards: none mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the leak was due to a blockage in the waste line conclusion: based on the investigation results, the root cause of the leak and why the aspirator arm could not acquire liquid was due to a blockage in the waste line.The field service engineer confirmed this issue when he flushed the waste line and the instrument was then ready to use.The safety risk of this hazard has been identified to be within the acceptable level.Supporting document: n/a.

• Brand Name: BD FACSCANTO¿
• Common Device Name: 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: 14644329
• Report Number: 2916837-2022-00149
• Device Sequence Number: 5550465
• Product Code: OYE
• UDI-Device Identifier: 00382906573384
• UDI-Public: 00382906573384
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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
• Operator of Device: Other
• Device Model Number: 657338
• Device Catalogue Number: 657338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown