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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting 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 there is waste leakage outside of the instrument with a bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: it was reported that the instrument is still leaking and not adding lyse.Additionally, on 2020-06-12 the fse provided the following additional information: called customer, the waste tower is not draining, they have cleaned the filter, replaced the filter, pushed & pulled water through the lines, still not draining properly.No change in safety data, not resolved, no follow up -- dispatched.Leak questions: was the leak contained within the instrument? n.Was the leak in a customer accessible location? y.What was the fluid that leaked? sheath, reagent, sample.What is the source of leak -- waste line or non-waste line? waste.Was the customer exposed to blood or bodily fluids? n.Was there any physical harm to the customer as a result of the leak n.

Event Description

It was reported that there is waste leakage outside of the instrument with a bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: it was reported that the instrument is still leaking and not adding lyse.Additionally, on 2020-06-12 the (b)(4) provided the following additional information: called customer, the waste tower is not draining, they have cleaned the filter, replaced the filter, pushed & pulled water through the lines, still not draining properly.No change in safety data, not resolved, no follow up -- dispatched.Leak questions: 1.Was the leak contained within the instrument? n.2.Was the leak in a customer accessible location? y.3.What was the fluid that leaked? sheath, reagent, sample.4.What is the source of leak -- waste line or non-waste line? waste.5.Was the customer exposed to blood or bodily fluids? n.6.Was there any physical harm to the customer as a result of the leak n.

Manufacturer Narrative

H.6.Investigation summary : (b)(4).Sn: (b)(6).Date reported: 06/12/2020.Scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported that the spa is leaking.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 12jun2019 to date 12jun2020 (rolling 12 months).Complaint trend: there are 5 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) related complaint(s) number: (b)(4) (this complaint).Investigation result / analysis: the investigation was performed and based on the fse report the leaking was coming from the wash tower.The customer was not exposed to the waste and no one was injured or hurt as a result of the leak.The cause of the leak was cap cores clogging the dcm waste pump and couplings on both sides of the waste line filter.The dcm waste pump head was removed, cleared of cores, cleaned and reassembled.The couplings between the wash tower and the pump were replaced to eliminate all remaining cores.This fixed the problem.The customer was informed on the proper assembly of the filter.Service max review: review of related work order #(b)(4).Install date: 01/31/2018.Defective part number: there were no defective parts.Work order notes: subject / reported: spa leaking.Problem description: wash station was overflowing.Cause: sample cap particles clogging waste pump.Work performed: cleaned the waste pump and replaced couplings.Solution: cleaned the waste pump.Returned sample evaluation: there were no defective parts.(b)(4) resolved the issue by clearing debris from the waste pump orifices.Couplings were replaced 640521 and 640587 and connection elbow 334453.Manufacturing device history record (dhr) review: review of the dhr for part number: 647205 and serial number: (b)(6) 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 the waste pump was clogged conclusion: based on the investigation results and the fse report the complaint was confirmed.H3 other text : see h.10.

• 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: 10236344
• MDR Text Key: 202544721
• Report Number: 2916837-2020-00039
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/12/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other