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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿ FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿ FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 342975
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Date 10/17/2022
Event Type  malfunction  
Event Description
It was reported that while using the bd facscalibur¿ flow cytometer that there was electrical shock.The following information was provided by the initial reporter: it presents discharges on the surface of the instrument.
 
Manufacturer Narrative
Initial reporter address: (b)(6).Initial reporter phone number: (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 the bd facscalibur¿ flow cytometer that there was electrical shock.The following information was provided by the initial reporter: it presents discharges on the surface of the instrument.
 
Manufacturer Narrative
H.6 investigation summary: scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975 and serial # (b)(6).Problem statement: customer reported a complaint regarding discharges present on the surface of the instrument on 17oct2022.Electrical discharges pose a risk of harming the customer by electrical shock.No problem was found with the instrument, and it was functioning as expected.There was improper wiring of the outlet which was corrected.The customer was neither injured nor harmed.The equipment is operational.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 17oct2021 to 17oct2022.¿ 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.¿ complaint history review: there are 4 complaints related to the filters of - as reported code 1 ¿ electrical/electronic and as analyzed code 1 - no device problem found; date range from 17oct2021 to 17oct2022.¿ returned sample analysis: a return sample was not requested because no parts were replaced.¿ service history review: review of related work order #:(b)(4).Install date: 25nov2015 work order notes: (b)(4).O subject / reported: presents discharges on the surface of the instrument o problem description: it presents discharges on the surface of the instrument.O work performed : the user was called who refused to follow instructions because she says she feels the electric shock every time she touches the table or the equipment.He was asked to disconnect the equipment and check if he perceives the discharge but asks for the visit of an engineer with meters to see the cause of the discharge.¿ cause: download the computer to the user.O solution: engineer's visit is required.¿ (b)(4).O subject / reported: presents discharges on the surface of the instrument.O problem description: it presents discharges on the surface of the instrument.O work performed : the electrical installation, cables, ups and transformers are checked.It is detected that the polarity of the outlet is reversed, which generates a voltage between ground and neutral of 12v at the output of the ups.The fault and low voltage is corrected to 0.4v.The line of the equipment is shared with a large centrifuge, it is requested to put an independent line for the cytometer with a thermal of 16 a.O cause: problems with the electrical installation.O solution: the equipment becomes operational.It is left under observation for a week.¿ (b)(4).O subject / reported: presents discharges on the surface of the instrument o problem description: it presents discharges on the surface of the instrument.O work performed: enrique franco is accompanied.The electrical installation, cables, ups and transformers are checked.It is detected that the polarity of the outlet is reversed, which generates a voltage between ground and neutral of 12v at the output of the ups.The fault and low voltage is corrected to 0.4v.The line of the equipment is shared with a large centrifuge, it is requested to put an independent line for the cytometer with a thermal of 16 a.O cause: problems with the electrical installation.O solution: the equipment becomes operational.It is left under observation for a week.¿ risk analysis: risk management file part # 342973ra, rev.04/vers.D, risk analysis facscalibur prod family was reviewed.This file did not contain the appropriate hazards and mitigations, and an eco has been opened to assess additional hazards and their risk levels.Ecr #500000276425 has been created and will revise the existing calibur risk analysis document to include causes, mitigations, and risk ratings related to electrical discharges.¿ potential causes: based on the investigation results, the potential cause of the discharges on the surface of the instrument was a problem with the electrical outlet, wall power.¿ investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause of the discharges on the surface of the instrument was a problem with the electrical installation.The customer reported a complaint regarding discharges present on the surface of the instrument.The customer felt weak electrical discharges and stopped using the equipment.The field service representative (fsr) identified that the polarity of the outlet was reversed and that there was no problem with the instrument or instrument performance.This is not a safety issue with the instrument.The customer was advised by the fsr, to disconnect the equipment and check if they perceive the discharge.However, the customer requested for a visit from the fsr.During the visit, the fsr checked the electrical installation, cables, ups and transformers.The fsr detected that the polarity of the outlet was reversed which generated a voltage between ground and neutral of 12 v at the output of the ups.The fsr corrected this, and the issue was resolved.The equipment is operational.The fsr also noted that the equipment line is shared with a large centrifuge and recommended the customer to put an independent line for the cytometer.There was no injury or harm to the customer.Optimal electrical requirements and environment is essential for functioning of the instrument at its optimal performance.This information can be found in the calibur site planning guide, #342883 rev.02/vers.A, on pages 7 and 8.Conclusion: based on the investigation results, the complaint was confirmed and the potential cause of the discharges on the surface of the instrument was a problem with the electrical installation, the wall outlet.The fsr identified that the polarity of the outlet was reversed and there was no problem with the instrument or instrument performance.This is not a safety issue with the instrument and there was no harm or injury to the customer.The fsr corrected this, and the issue was resolved.The equipment is operational.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.
 
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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 Key15754793
MDR Text Key307701233
Report Number2916837-2022-00335
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903429752
UDI-Public00382903429752
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K923790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number342975
Device Catalogue Number342975
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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