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

Model Number 647205

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis medical device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using bd facs" sample prep assistant iii blood waste leaked outside of instrument.There was no report of customer or patient impact.The following information was provided by the initial reporter: it was reported that the wash tower overflowed.Are you using this product for clinical diagnostic test? yes were erroneous results reported and used to treat a patient? no was there any injury or potential injury? no leak (if yes explain)? yes.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? no.What was the fluid that leaked? blood & water.What is the source of leak -- waste line or non-waste line? unknown.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak no.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii blood waste leaked outside of instrument.There was no report of customer or patient impact.The following information was provided by the initial reporter: it was reported that the wash tower overflowed.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Leak (if yes explain)? yes.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? no.3.What was the fluid that leaked? blood & water.4.What is the source of leak -- waste line or non-waste line? unknown.5.Was the customer exposed to blood or bodily fluids? no.6.Was there any physical harm to the customer as a result of the leak? no.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaii and serial number: (b)(6).Problem statement: customer reported: wash tower overflow.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2019 to date (b)(6) 2020 (rolling 12 months) complaint trend:there are 9 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2019 to date (b)(6) 2020 (rolling 12 months) ¿ investigation result / analysis: per fse report: the leak was coming from the wash tower because 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.The fluid was not under any type of pressure.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 1809 piercings and was lot# f164970.Photos are attached to the work order.The miniwash pump assembly was replaced as well as the couplings to avoid any further cores from going downstream past the filter.The filter was inspected.The instrument was tested and verified as operating to specs.The problem was corrected and there was no further leaking or blockage.Service max review: review of related work order # (b)(4).Install date: 01sep2009.Defective part number: there were no defective parts.Parts were replaced as a precaution.Pn334297, 640520, 640521.Work order notes: subject / reported: wash tower overflow.Problem description: clogged waste pump.Cause: clogged waste pump.Work performed: replaced miniwash pump assembly.Solution: replaced miniwash pump assembly.Returned sample evaluation: there were no defective parts.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: risk management file part (b)(4), revision 02 was reviewed.Hazard(s) identified? yes or no.Hazard id: (b)(4).Hazard: environmental biohazard.Severity: 5.Probability: 1.Risk index: 5.Implementation: bd facs sample prep user¿s guide.Risk control:_alarp.Mitigation(s) sufficient? yes or no.Root cause: based on the investigation result, and the fse¿s report the root cause was clogged waste pump.Conclusion: based on the investigation results and the fse report the complaint was confirmed for the waste leakage.

• 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
• MDR Report Key: 10943355
• MDR Text Key: 219551446
• Report Number: 2916837-2020-00286
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1