MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD ACCURI¿; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Catalog Number 660517

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd accuri¿ that there was a leak.The following information was provided by the initial reporter: this was potentially biohazardous fluid, which was after the waste line.The fluid was not contained (but there was no spray) and it was not mixed with bleach/decontamination.The customer did not come in contact physically with the leaked liquid without ppe however, so nobody was harmed.The customer reports that the instrument leaks from the fluidics harness connector.

Manufacturer Narrative

The event described occurred on an ruo instrument, but it is considered to be substantially similar to the legally u.S.Marketed ivd version of the instrument.The ivd instrument¿s 510k has been reported.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: investigation summary: ¿ scope of issue: the scope of issue is only limited to bd accuri c6 plus system, part # 660517, and serial # (b)(6).¿ problem statement: the customer reported a complaint of fluidic leakage from the fluidics harness connector on 15nov2022.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue with part # 660517.Date range from 15nov2021 to date 15nov2022.¿ device history record (dhr) review: dhr part # 660517 serial # (b)(6), file # (b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ complaint history review: there are 8 complaints related to the issue of a leak from clog or valves for part # 660517.Date range from 15nov2021 to date nov152022.¿ returned sample analysis: complaint samples were not requested because the replaced parts confirmed they resolved the issue of the leak.¿ service history review: review of related work order #: (b)(4).Install date: 13jul2016.Defective part number: (see replaced parts below).Work order (b)(4) notes: subject / reported: 660517 - bd accuri c6 plus - leakage from fluidics harness connector problem description: the customer reports that the instrument leaks from the fluidics harness connector.Work performed: changed partial blocked waste bottle connector (floorstock) performed pm: replaced pump tubing¿s (653146) and inline-sheath filter (653148) (standard procedure).Cleaned fluidic harness with hot water.Replaced all internal tubings (floorstock), replaced passthru connectors (floorstock) replaced valve board (660484 ) by new valves & valveboard pcb.Complete valveboard 660484 is in backorder.Replaced t fitting and tubing¿s at pressure sensor (floorstock).Replaced sip o-rings (floorstock).Replaced dampeners by new dampeners (660490) replaced level sensor manifold with harness socket (659608) performed fluidic calibration.Replaced detergent-(661276) & deconbottle (661275).Cause: partial blocked waste bottle connector.Blocked dampeners, blocked valves due degraded o-rings in passthrough connectors.Solution: work / repair performed at european instrument service center.This instrument is repaired and working according bd service specifications.Spare part order number lots : to2 u06908221 (b)(4) - c6+ ac66051710115 labor hours : 19 h.Parts replaced: - 653146 - tubing peristaltic pump (set of 2).- 653148 - filter in-line sheath (1).- 658479 - assy valve board gen iv pcba.- 658454 - valve 12vdc vac to 30 psig 1/16 id 2w nc.- 658455 - valve r 12vdc vac to 30 psig 1/16 id 3-w.¿ labeling / packaging review: n/a.¿ risk analysis: risk management file part # (b)(4), rev.01/vers.A, bd accuri c6 plus risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes/ no.Id: 2.1.9.Hazard: exposure to bio-hazardous material during preventative maintenance.Cause: user disconnects the fluidics harness and spills sample waste fluid.Harmful effects: exposure to bio hazardous material.Residual probability: 1.Residual severity: 4.Residual risk index: 4.Residual risk evaluation: a.New hazards: none.¿ potential causes: based on the investigation, the potential cause of the of the waste leak was due to several items; partially blocked waste-bottle connector, blocked dampeners, blocked valves and a worn o-ring.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr risk analysis, and servicemax, the potential cause of the waste leak was due to a combinations of issues; partially blocked waste-bottle connector, blocked dampeners, blocked valves and a worn o-ring.The fse (field service engineer) performed a standard pm (preventative maintenance) service and confirmed all the issues.They replaced many floor-stock parts and other main components such as 653146 - tubing peristaltic pump (set of 2), 653148 - filter in-line sheath (1), 658479 - assy valve board gen iv pcba, 658454 - valve 12vdc vac to 30 psig 1/16 id 2w nc, and 658455 - valve r 12vdc vac to 30 psig 1/16 id 3-w.After the extensive repair the instrument was up and running as expected with no adverse leaks.No parts were requested for evaluation as the replaced parts resolved the customer¿s issue.Although, the event type leak of biohazard not contained within the instrument, there was no spray and the customer did not come in contact physically with the leaked liquid without ppe (personal protective equipment), so nobody was harmed or injured to biohazard exposure, per dt 7241962.The safety risk of this hazard has been identified to be within the acceptable level.¿ conclusion: based on the investigation, the complaint was confirmed, and the potential cause of the waste leak was due to several items; partially blocked waste-bottle connector, blocked dampeners, blocked valves and a worn o-ring.The fse replaced multiple components and parts which resolved the customer¿s issue.The instrument was back up and running with no adverse leaks.The customer was not harmed or injured to any biohazard exposure.The safety risk of this hazard has been identified to be within the acceptable level.Based on the investigation results, a capa is not required because there was no impact to customer and patient health or safety.¿ supporting document: n/a.

Event Description

Hold for cs 03.14.24! it was reported that while using the bd accuri¿ that there was a leak.The following information was provided by the initial reporter: this was potentially biohazardous fluid, which was after the waste line.The fluid was not contained (but there was no spray) and it was not mixed with bleach/decontamination.The customer did not come in contact physically with the leaked liquid without ppe however, so nobody was harmed.The customer reports that the instrument leaks from the fluidics harness connector.

• Brand Name: BD ACCURI¿
• Type of Device: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• 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 ; 8448235433
• MDR Report Key: 16457227
• MDR Text Key: 310858604
• Report Number: 2916837-2023-00047
• Device Sequence Number: 1
• Product Code: OYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: BK150307
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 660517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• 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