MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10

Model Number 647205

Device Problems Excess Flow or Over-Infusion (1311); Mechanical Problem (1384)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd facs¿ sample prep assistant iii that the wash tower is overflowing and the lock is not functioning.The following information was provided by the initial reporter: wash tower overflowing and lock not functioning.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.

Event Description

It was reported that while using the bd facs¿ sample prep assistant iii that the wash tower is overflowing and the lock is not functioning.The following information was provided by the initial reporter: wash tower overflowing and lock not functioning.

Manufacturer Narrative

H.6 investigation summary pr6201282, pn: 647205, spaiii, sn: (b)(6), awareness: 09/30/2022 opened: 09/30/2022.¿ investigation summary: ¿ scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).¿ problem statement: customer reported: wash tower overflowing/door lock not working.¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months).¿ complaint trend: there are 7 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 30sep2021 to date 30sep2022 (rolling 12 months) complaint data attached.¿ investigation result / analysis: per fse¿s report: the leak was coming from the wash tower due to the waste line was backed up from blockage in the waste pump head assembly.The leak was waste, and fluids used for the instrument operations such as sheath, di water and lyse.There was no bodily contact or harm to the customer or fse caused by the leak however the leak was not contained within the instrument.Bleach was used to clean and disinfect the instrument and surrounding areas.The clog in the waste pump head was due to cores from the yellow vacutainer caps.The tubes used are bd vacutainer acd solution a #364606.The probe had 1800 piercings and was lot# f164970.The blockage was cleared after disassembling the head and flushing with di water.The pump was reassembled, and the couplings were replaced to avoid any further cores from going downstream past the filter.The filter was inspected.The problem was corrected and there was no further leaking or blockage.O second issue was the safety door lock not locking.This was due to bad sensors for the door as well as the solenoid sensors.After replacing the sensors, the problem was corrected.O tested and verified instrument performance.O no further issues.O sample preparation was not affected.O there was no delay in patient treatment due to any unexpected results.¿ service max review: review of related work order#: wo - (b)(4).Install date: 01sep2009.Defective part number: 364606 ¿ tube acd.Work order notes: o subject / reported: wash tower overflowing/door lock not working.O problem description: fluid leak/sensor failure.O cause: overflow caused by clogged pump and filters/sensor failure.O work performed: cleared blockage from pump/replaced sensor.O solution: cleared blockage from pump and fluidic lines/replaced sensor.O parts replaced: 364606 ¿ tube acd/ (sensor part number not reported).¿ returned sample analysis: the complaint sample was not requested to be returned and no photo(s) / picture(s) were provided.¿ manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: o risk management file part #100245ra, revision 03 was reviewed.O hazard(s) identified? ¿yes ¿no.¿ hazard id: 3.1.29.¿ hazard: environment biohazard.¿ cause: filter/components in fluid path get clogged.¿ harmful effects: exposure to biohazard.¿ residual severity: 5.¿ residual probability: 1.¿ residual risk index: 5.¿ root cause: based on the investigation result and fse¿s report the root cause was clogged pump and fluidic lines/sensor failure.¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash tower overflowing and door lock not working.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Type of Device: SEE H.10
• 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: 15811182
• MDR Text Key: 306878535
• Report Number: 2916837-2022-00348
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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