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

Model Number 342975

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock (2072)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.(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 when trying to clean the sensor the customer felt a slight shock with a bd facscalibur flow cytometer.The following information was provided by the initial reporter, translated from (b)(6) to english: the client informed that when changing the solutions of the reservoirs, he noticed that the waste sensor was rusty, he even observed a rust stain on the bottom of the reservoir.When trying to clean the sensor with paper, the customer reported having felt a slight shock.Additionally, on (b)(6) 2020 the bd sales consultant provided the following additional information: during the call, the customer with our help desk support did not identify any loose wire.The instrument installations were within specifications.However, the tip of the waste sensor was corroded and rusted.As this sensor is in contact with hypochlorite, it caused rust.Resolution: it was recommended the replacement of the waste sensor (pn: 02-60790-01s).Additionally, on (b)(6) 2020 the bd sales consultant provided the following additional information: according to the fas who was in contact with the customer, there was no harm to the customer, no medical intervention needed, it was as described at the event description a ¿slight shock¿.It was not possible determinate the cause of the shock through remote access.For this case, a wo will not be dispatched.The customer has no service agreement contract.The replacement of the waste sensor is been evaluated through a quote by the customer.

Event Description

It was reported that when trying to clean the sensor the customer felt a slight shock with a bd facscalibur flow cytometer.The following information was provided by the initial reporter, translated from portuguese to english: the client informed that when changing the solutions of the reservoirs, he noticed that the waste sensor was rusty, he even observed a rust stain on the bottom of the reservoir.When trying to clean the sensor with paper, the customer reported having felt a slight shock.Additionally, on 2020-04-28 the bd sales consultant provided the following additional information: during the call, the customer with our help desk support did not identify any loose wire.The instrument installations were within specifications.However, the tip of the waste sensor was corroded and rusted.As this sensor is in contact with hypochlorite, it caused rust.Resolution: it was recommended the replacement of the waste sensor (pn: 02-60790-01s).Additionally, on 2020-05-06 the bd sales consultant provided the following additional information: according to the fas who was in contact with the customer, there was no harm to the customer, no medical intervention needed, it was as described at the event description a ¿slight shock¿.It was not possible determinate the cause of the shock through remote access.For this case, a wo will not be dispatched.The customer has no service agreement contract.The replacement of the waste sensor is been evaluated through a quote by the customer.

Manufacturer Narrative

H.6.Investigation summary scope of issue: the scope of issue is only limited to part # 342975 and serial # (b)(4).Problem statement: customer reported complaint on a facscalibur 342975 that they felt a slight shock while cleaning the waste sensor.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 23apr2019 to date 23apr2020.Complaint trend: this is the only complaint, #1544065.Date range from 23apr2019 to date 23apr2020.Manufacturing device history record (dhr) review: review of dhr part # 342975 and serial # (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, and risk analysis, the root cause of the reported complaint could not be determined.The instrument installations were within specifications.There are no manufacturing defects nor similar complaints.Photos of the sensor and the reservoir were reviewed.Although the photo verifies the tip of the waste sensor was corroded and rusted it could not be confirmed if this caused the ¿slight shock¿.For safety awareness the bd facscalibur¿s instructions for use (ifu, #23-12911-02) states, ¿use universal precautions when cleaning the instrument or replacing parts.Wear suitable protective clothing, eyewear, and gloves,¿ throughout the maintenance section (8), starting on page 173.Because the customer has no service agreement, no work order nor an fse was carried out and dispatched.Over the phone, the fas (field applications specialist) recommended the customer to have the waste sensor replaced as a resolution.This was an isolated incident, in which there was no harm to the customer and no medical intervention needed.The safety risk is low because there was no impact to customer health or safety.Service max review: review of related work order # n/a, case #01021687.Install date: 31jan2018.Defective part number: n/a.Work order notes: n/a.Case notes: the client informed that when changing the solutions of the reservoirs, he noticed that the waste sensor was rusty, he even observed a rust stain on the bottom of the reservoir.When trying to clean the sensor with paper, the customer reported having felt a slight shock.Returned sample evaluation: there were no replaced parts reported.Risk analysis: risk management file part #342973ra rev #03, bd facscalibur product family was reviewed.File 342973ra identifies the hazard ¿mechanical hazard/potential injury¿; however, the file will be revised to include additional mitigations documented in the investigation result/analysis.Eco# 500000177219 was initiated to make this change.Root cause: based on the investigation results the root cause of a "slight shock" was not determined.Conclusion: based on the investigation results, this complaint was unconfirmed.Although the provided pictures show rust on the tip of the waste sensor, the cause of the ¿slight shock¿ could not be determined.For user safety, the ifu provides proper cleaning and maintenance recommendations.The safety risk is low because there was no impact to customer health or safety.Supporting document: n/a.

• 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
• MDR Report Key: 10066573
• MDR Text Key: 221296008
• Report Number: 2916837-2020-00013
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other