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 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Common device name: automated pipetting, dilutin and specimen processing workstations for flow cytometric analysis.Medical device expiration date: na.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 waste leaked outside of instrument.There was no reported impact to user or patient.The following information was provided by the initial reporter: wash station over flows intermittently.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? sheath and waste.Was the spray of fluid under pressure? no.What is the source of leak - waste line or non-waste line? waste line.Was the customer exposed to bio-hazard fluids (example: blood, tissue, waste)? no.If customer was exposed, how were they exposed? (clothing, skin, mucous membrane, or non-intact skin) no.Was personal protective equipment (ppe) being worn? yes.Was bio-hazard fluid mixed with bleach? no.Was there any physical harm/injury or impact to patient samples due to leak? no.If customer was harmed/injured, provide details - how and to what extent? no.If there was patient harm, what is the current medical status? no.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.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii waste leaked outside of instrument.There was no reported impact to user or patient.The following information was provided by the initial reporter: wash station over flows intermittently.1.Was the leak contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.What was the fluid that leaked? sheath and waste.4.Was the spray of fluid under pressure? no.5.What is the source of leak - waste line or non-waste line? waste line.6.Was the customer exposed to bio-hazard fluids (example: blood, tissue, waste)? no.7.If customer was exposed, how were they exposed? (clothing, skin, mucous membrane, or non-intact skin) no.8.Was personal protective equipment (ppe) being worn? yes.9.Was bio-hazard fluid mixed with bleach? no.10.Was there any physical harm/injury or impact to patient samples due to leak? no.11.If customer was harmed/injured, provide details - how and to what extent? no.12.If there was patient harm, what is the current medical status? no.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.

Manufacturer Narrative

H6: investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaii and serial number: (b)(6).Problem statement: customer reported: wash station overflows intermittently manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 16nov2019 to date 16nov2020 (rolling 12 months).Complaint trend:there are 10 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 16nov2019 to date 16nov2020 (rolling 12 months).(b)(4) (this complaint).Investigation result / analysis: per fse report: the filter was checked, as were the tubing and quick connect fittings.The wash tower was removed and thoroughly purged.It was suspected to be a bad waste pump or wash tower as there seemed to be large amounts of air being drawn from the wash tower.After replacing pump and re directing tubing the instrument showed much better improvement.Ran several primes and cleaning procedure and shutdowns trying to check if it overflowed.System performed good without errors or overflow.Ran a&p dispense and system is running well.Service max review: review of related work order #(b)(4).Install date: 18sep2013.Defective part number: 334297 miniwash assembly.Work order notes: subject / reported: wash tower overflows intermittently.Problem description: defective waste pump.Cause: defective waste pump.Work performed: replaced miniwash pump assembly.Solution: replaced miniwash pump assembly.Returned sample evaluation: return of defective part was not requested.Manufacturing device history record (dhr) review: review of the dhr for serial number: x0304 and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 02 was reviewed.Hazard(s) identified? ¿yes ¿no.Hazard id: 3.1.29.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 ¿no.Root cause: based on the investigation result, and the fse¿s report the root cause was defective miniwash pump.Conclusion: based on the investigation results and the fse report the complaint was confirmed for the wash station overflow.H3 other text : see h10.

• 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: 10969970
• MDR Text Key: 247274691
• Report Number: 2916837-2020-00296
• 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: 07/02/2021

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: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1