MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSARIA¿ III; FLOW CYTOMETER

Catalog Number 648282D1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tingling (2171); Numbness (2415); Electric Shock (2554)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: scope of issue: the scope of issue is limited to part number 648282d1, aria iii acdu 3b/3r/3v/5yg/2nuv, serial number (b)(4).Problem statement: on 05mar2020, bd was made aware of an event involving a customer who opened the safety chamber of a facsaria instrument while the high voltage (hv) was attached to the deflection plates, gripped one of the plates and subsequently suffered an electric shock, which caused tingling and numbness in her right arm.Manufacturing defect trend: there are no qns (quality notifications) related to the reported issue.Date range (date of incident to 12 months back) from 04-mar-2019 to date 04-mar-2020 (rolling 12 months).Complaint trend: complaint query for similar complaints with the same as reported codes (electrical- shock) for date range (date of incident to 12 months back) from 04-mar-2019 to date 04-mar-2020 (rolling 12 months) yielded 2 results: manufacturing device history record (dhr) review: review of dhr part number 648282d1 and serial (b)(4).Was performed.The instrument was manufactured on june 2010.The instrument met all the manufacturing specifications prior to release.Reference: from documentum product history library: file name: 648282d1-p28200063-900250441-10.Pdf.Service record review: instrument was installed at customer site on (b)(6) 2010.Defective part number: no defective components.0 work order notes: subject / reported: 648282d1 - aria iii acdu 3b / 3r / 3v / 5yg / 2nuv, electric shock on the deflection plates.Problem description: the customer opened the safety chamber while the hv was attached to the deflection plates, gripped one of the plates and subsequently suffered an electric shock, which caused tingling and numbness in her right arm, which the customer had examined under including an ekg, no abnormalities were found.I have just spoken to the customer, she no longer feels any of the above symptoms.The incident is not due to a device fault, the hv led on the sorting chamber is ok, the warnings are also there.The aria is designed to open the sorting chamber when the hv panels are on to see if the side streams are ok.Cause: no device error.Work performed: talked to the customer, nothing unusual was found during the examination, and there are no after effects.Solution: heed warnings.Returned sample evaluation: no samples requested to be returned since there were no reported issue with the instrument.There were no damaged/defective components which requires replacement per service report (b)(4).Risk analysis: facsaria product family risk analysis, p/n 648282ra , rev.07 was reviewed as part of risk analysis.The reported complaint is captured within section id 1.1.13 with the following evaluation: hazard: user is exposed to shock hazard.Cause: high voltage (6kv) arcs to nearby metal components accessible by user.Harmful effects: operator injury.Occurrence level = 1 (improbable).Risk index = 5 alarp (as low as reasonably practicable).Severity level: 5 (catastrophic - fatal or life threatening).Risk control: high voltage posts moved to sides of sort block where fluid spill is both highly likely and visible to user (aria ii).All conductive surfaces in the high voltage wires and connection posts external to sort block are insulated(aria).Teflon seal around electrical connector prevents fluid from entering connector (aria ii).Led indicator and labeling near high voltage plates and connectors (aria).High voltage led moves to a more highly visible location (aria ii).Residual risk evaluation: likelihood of electrical shock to user has been reduced to lowest probability; however, severity of an electrical hazard places this in alarp (as low as reasonably possible).In addition to risk controls indicated on the risk assessment document, the following are additional mitigation for electrical shock.Facsaria iii user's guide, p/n 23-15132-01, rev 01 documents the risk of shock when operating the instrument with the deflection plates turned on, within pages: xiv table 1, 26, 32, 170, 206, 239, 241, with instructions to avoid electrical shock.Facsaria safety and limitations guide, p/n 23-11656-00, rv.02 lists shock warnings on pages 4 and 8.On the instrument, a red deflection plate warning light illuminates when deflection plates are on and an electrical shock symbol label is indicated next to the warning light and on the sort block door to visually remind user of electrical hazard.Refer to attached diagram of location of deflection plates warning light and electric shock labels.The facsaria instrument is certified by a third party test lab, to comply with iec61010-1, electrical safety requirements for laboratory equipment.No hazardous exposure to direct high voltage is allowed per the iec61010-1 standard.Reference: document # (b)(4) - nrtl report facsariaiii safety 61010-1.Bd facsaria operator course training offered for customers.During the training, instructors explain and inform the customers about the high voltage on the deflection plates and that user should not touch the plates as mentioned in the safety and limitations guide delivered with the instrument.Note: review of training record confirms that the customer contact, (b)(6), completed an advance bd facsaria operator course on (b)(6) 2019 at bd (b)(6) training center in (b)(6).Training record attached in complaint record for reference.Overall review of risk assessment document shows sufficient risk controls are in place to reduce the probability of electrical shock hazard.The hazard is captured in the risk assessment document; therefore, no update to the risk assessment document is required at this time.Investigation result / analysis: on 05mar2020, bd was made aware of an event involving a customer who opened the safety chamber of a facsaria instrument while the hv was attached to the deflection plates, gripped one of the plates and subsequently suffered an electric shock, which caused tingling and numbness in her right arm.Follow up performed by bd service on (b)(6) 2020 confirmed that customer no longer feel any of the above symptoms.The investigation was performed and based on the event description and service report, the reported complaint was confirmed.Review of dhr, manufacturing and complaint trend shows that the incident are isolated occurrences, not a systemic issue.Risk assessment and review of instrument manual and instrument labeling shows there are sufficient risk controls and mitigation in place warning users of the hazard associated with electric shock when operating the instrument with the deflection plates turned on.Service report shows there were no device error/instrument defect found that would have attributed to the reported complaint.The facsaria instrument is designed to allow opening of the sorting chamber when the hv plates are on to see if the side streams are working as intended.As bd field service engineer confirmed, the instrument was functioning as intended and the high voltage indicator warning lights were illuminated when the deflection plates are on.Based on the training record, and user manuals, user was sufficiently informed about the risk.As such, root cause is associated to user error for inadvertently touching the deflection plates, not heeding the precautionary warnings for electrical danger.Conclusion: investigation was performed and based on the review of complaint trend, defect trend, dhr review, root cause and risk analysis, the reported complaint was confirmed.This incident is considered as a safety risk and is captured within the risk analysis document.Sufficient risk controls are in place to reduce risk to as low as reasonably practicable.The facsaria instrument is certified by a third party test lab, to comply with iec61010-1, electrical safety requirements for laboratory equipment.Follow-up with customer confirmed there were no adverse harm/injury from the event.There were no device error/instrument defect found that would have attributed to the reported complaint.Root cause is determined to be due to user error for incorrectly touching the deflection plates while on, and not heeding the electrical danger warning labels on the instrument.Complaints received for this device and reported condition, will continue to be tracked and trended.Information will be captured on trend reports and monitored.No additional escalations required at this time.Root cause: root cause is associated to user error for inadvertently touching the deflection plates, not heeding the precautionary warnings for electrical danger.

Event Description

It was reported that an electric shock occurred while opening the safety chamber on a bd facsaria¿ iii.Medical intervention was performed (ekg).No abnormalities were found.No further information has been provided.The following information was reported in the event description: the customer opened the safety chamber while the hv was attached to the deflection plates, gripped one of the plates and subsequently suffered an electric shock, which caused tingling and numbness in her right arm, which the customer had examined under including an ekg, no abnormalities were found.I have just spoken to the customer, she no longer feels any of the above symptoms.The incident is not due to a device fault, the hv led on the sorting chamber is ok, the warnings are also there.The aria is designed to open the sorting chamber when the hv plates are on to see if the side streams are ok.

• Brand Name: BD FACSARIA¿ III
• Type of Device: FLOW CYTOMETER
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9844743
• MDR Text Key: 196794190
• Report Number: 2916837-2020-00002
• Device Sequence Number: 1
• Product Code: OYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 648282D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other