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

Catalog Number 343202

Device Problems Fluid/Blood Leak (1250); Output Problem (3005)

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

Event Date 11/15/2022

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 the bd facscalibur¿ that the equipment drips through the needle with the arm open and there is no noise from the bomb.The following information was provided by the initial reporter: the equipment drips through the needle with the arm open and there is no noise from the bomb.

Manufacturer Narrative

H.6 investigation summary: scope of issue: the scope of issue is only limited to facscalibur 4 clr basic sensor unit, part # 343202 and serial # (b)(6).Problem statement: the customer reported a complaint regarding a drip from the needle and that there was no noise from the pump on 15nov2022.This poses the risk of harming or injuring the customer or patient due to contact with the fluid.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 15nov2021 to 15nov2022.Device history record (dhr) review: dhr part # 343202 serial # (b)(6), file # 343202-940635-e4775 and 343202-940635-e4775-02, was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 38 complaints related to as reported code 1: fluidic ¿ leak.Then further filtered by as analyzed code 1, there are 27 complaints remaining, date range from 15nov2021 to 15nov2022.Returned sample analysis: a return sample was not requested because parts replaced are not returnable.Service history review: review of related work order #: 02721915, case # (b)(4).Install date: 25mar2002.Defective part number: 660049 - pump tubing 12vdc 35rpm 1.4-18ml/min; 349532 - assy switch pressure 10psi.Work order notes: subject / reported: 343202 - facscalibur 4 clr basic sensor unit.Problem description: the equipment drips through the needle with the arm open and there was no noise from the pump.Work performed : replacement of biohazard pump and overpressure sensor of waste line.Checking the performance of the equipment with red nile + blue beads ok.Cause: biohazard pump + pressure switch failure.Solution: replaced defective components.Parts replaced: 660049 - pump tubing 12vdc 35rpm 1.4-18ml/min; 349532 - assy switch pressure 10psi.Labeling / packaging review: n/a.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 fluidic-leak.Potential causes: based on the investigation results, the potential cause was defective biohazard pump and failure of pressure switch.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 drip was a defective biohazard pump and failure of pressure switch.The customer reported a complaint regarding a drip from the needle and that there was no noise from the pump.The field service representative (fsr) confirmed that the biohazard pump and waste line over pressure sensor were defective and proceeded to replace them.After the replacement of the defective components, the instrument was tested and was functioning as expected.Although the leak was biohazardous waste, there was no skin contact with the fluid.No user was harmed or injured as a result of the leak.Conclusion: based on the investigation results, complaint was confirmed and the potential cause of the drip was a defective biohazard pump and failure of pressure switch.The customer reported a complaint regarding a drip from the needle and that there was no noise from the pump.The field service representative (fsr) confirmed that the biohazard pump and waste line over pressure sensor were defective and proceeded to replace them.After the replacement of the defective components, the instrument was tested and was functioning as expected.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.Supporting document: n/a.

Event Description

It was reported that while using the bd facscalibur¿ that the equipment drips through the needle with the arm open and there is no noise from the bomb.The following information was provided by the initial reporter: the equipment drips through the needle with the arm open and there is no noise from the bomb.

• Brand Name: BD FACSCALIBUR¿
• 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: 15873224
• MDR Text Key: 307091437
• Report Number: 1119779-2022-01429
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 343202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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