MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number 342973

Device Problem Contamination (1120)

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

Event Date 04/12/2022

Event Type  malfunction  

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 facscalibur flow cytometer carryover between patient samples had occurred.The following information was provided by the initial reporter: "it was reported that there is a sip drip.Customer problem: sip drip.Steps taken with customer/troubleshooting: ongoing issue.Next steps (if necessary): referring case to field service.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? no.Follow up required? yes.Software version? unknown.Was there a fluidic leak or spill? yes.Was the leak/spill contained within the instrument? yes.Was the leak/spill in a customer accessible location? no.What was the fluid that leaked/spilled? sheath.What is the source of leak/spill? (waste or non-waste line) sip.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.Caller reports that they cannot run as there is carryover.

Event Description

It was reported that while using bd facscalibur flow cytometer carryover between patient samples had occurred.The following information was provided by the initial reporter: "it was reported that there is a sip drip.Customer problem: sip drip steps taken with customer/troubleshooting: ongoing issue next steps (if necessary): referring case to field service are you using this product for clinical diagnostic test? yes were erroneous results reported and used to treat a patient? no was there any injury or potential injury? no resolution achieved? no follow up required? yes software version? unknown was there a fluidic leak or spill? yes 1.Was the leak/spill contained within the instrument? yes 2.Was the leak/spill in a customer accessible location? no 3.What was the fluid that leaked/spilled? sheath 4.What is the source of leak/spill? (waste or non-waste line) sip 5.Was the customer exposed to blood or bodily fluids? no 6.Was there any physical harm to the customer as a result of the leak? no caller reports that they cannot run as there is carryover".

Manufacturer Narrative

H6.Investigation summary: ¿ scope of issue: the scope of issue is only limited to facscalibur cytometer 3 color basic ivd, part # 342973, serial # (b)(6).¿ problem statement: customer reported a complaint regarding the instrument producing high carryover.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 12apr2021 to date 12apr2022.¿ complaint trend: the only complaint related to the issue of carryover for this part number within the date range was this one; date range from 12apr2021 to date 12apr2022.¿ manufacturing device history record (dhr) review: dhr part #342973 serial # (b)(6).File # 342973-e97300049-900057838-06, 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 carryover between sample tests was due to a clog in the dcm line.The customer had reported that they were not able to proceed with their operations as they were observing carryover with their instrument.A fse (field service engineer) was sent onsite for the repair and they were able to confirm the issue.The fse cleared the dcm line from its clog and the instrument was functioning as expected.No parts were requested for evaluation as there were no parts replaced.Although the unexpected results were from patient samples who may be affected by an incorrect analysis of their samples, no patient was treated nor harmed from incorrect results.There was no delay in patient treatment due to any unexpected results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; instr for use facscalibur ivd en, # 23-12911-02 rev.1/vers.A.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: 02411025, case # 01656952 install date: 08may2006 defective part number: n/a work order notes: o subject / reported: sip drip o problem description: caller reports that they cannot run as there is carryover o work performed: cleared clog in dcm line o cause: dcm line clog o solution: instrument in fine working order after repair.¿ returned sample evaluation: a return sample was not requested because there was no replaced part.¿ risk analysis: risk management file part # 342973-01ra, rev.01/vers.A, risk anal facs calibur 3 color basic ivd was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? ¿yes ¿no o item: droplet containment module o function: to contain droplets o potential failure mode: droplets are not contained o potential effect(s) of failure: all of the sample is¿ o potential cause(s)/mechanism(s) of failure: pump not properly sealed o current controls: n/a o initial severity: 5 o initial occurrence: 5 o initial detection: 1 o rpn: 25 mitigation(s) sufficient ¿yes ¿no ¿ root cause: based on the investigation results the root cause of the carryover was confirmed to be due to a clogged dcm line.¿ conclusion: based on the investigation results the root cause of the carryover was confirmed to be due to a clogged dcm line.The fse confirmed the issue and cleared a clog from the dcm line.After the cleaning, the instrument was tested and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.

• Brand Name: BD FACSCALIBUR 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: 14138616
• MDR Text Key: 289508496
• Report Number: 2916837-2022-00101
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429738
• UDI-Public: 00382903429738
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 342973
• Device Catalogue Number: 342973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• 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