Model Number 647205 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that bd facs¿ sample prep assistant iii is leaking biohazard from the wash tower.The following information was provided by the initial reporter: wash tower is flooding.Apparently the sensor on the waste tank stopped working and it was not giving an error that the waste was full.Leak (if yes explain)? yes.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that was leaked? "unknown".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.Was there spray or fluid under pressure no.
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Manufacturer Narrative
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H.6.Investigation: ¿ scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: wash station is flooding manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6)2021 (rolling 12 months) complaint trend: there are 11 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6)2021 (rolling 12 months).Investigation result / analysis: per fse call report: customer technician found that the sensor on the waste tank stopped working and it was not giving an error that the waste was full.Customer technician replaced the waste sensor, and everything is working properly.Problem resolved; case closed service max review: review of related work order# no wo was issued for this complaint install date: (b)(6) 2009.Defective part number: part number not reported work order notes: o subject / reported: wash station is flooding.O problem description: fluid leak.O cause: waste sensor not working.O work performed: replaced waste sensor.O solution: replaced waste sensor.Returned sample evaluation: did not request return of defective parts manufacturing device history record (dhr) review: review of the dhr for serial number: x0011 and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: o risk management file part #100245ra, revision 02 was reviewed.O hazard(s) identified? ¿yes ¿no.¿ hazard id: 3.1.29 _ ¿ hazard: environmental biohazard.¿ severity: 5.¿ probability: 1.¿ risk index: 5.O implementation: bd facs sample prep user¿s guide.O risk control:_alarp.O mitigation(s) sufficient ¿yes ¿no.Root cause: based on the investigation result and the fse¿s call report the root cause was waste sensor not working.Conclusion: based on the investigation results and the fse¿s call report the complaint was confirmed for the wash station flooding.
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Event Description
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It was reported that bd facs¿ sample prep assistant iii is leaking biohazard from the wash tower.The following information was provided by the initial reporter: "wash tower is flooding.Apparently the sensor on the waste tank stopped working and it was not giving an error that the waste was full.Leak (if yes explain)? yes.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 was leaked? "unknown." 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.7.Was there spray or fluid under pressure no.".
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Manufacturer Narrative
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H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: wash station is flooding.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Complaint trend: there are 11 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Complaint data attached: investigation result / analysis: per fse call report: customer technician found that the sensor on the waste tank stopped working and it was not giving an error that the waste was full.Customer technician replaced the waste sensor, and everything is working properly.Problem resolved; case closed.Service max review: review of related work order# no wo was issued for this complaint.Install date: 10sep2009.Defective part number: part number not reported.Work order notes: subject / reported: wash station is flooding.Problem description: fluid leak.Cause: waste sensor not working.Work performed: replaced waste sensor.Solution: replaced waste sensor.Returned sample evaluation: did not request return of 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 #100245ra, revision 03 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 call report the root cause was waste sensor not working.Conclusion: based on the investigation results and the fse¿s call report the complaint was confirmed for the wash station flooding.
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Event Description
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It was reported that bd facs¿ sample prep assistant iii is leaking biohazard from the wash tower.The following information was provided by the initial reporter: "wash tower is flooding.Apparently the sensor on the waste tank stopped working and it was not giving an error that the waste was full.Leak (if yes explain)? yes.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 was leaked? "unknow." 4.What is the source of leak -- waste line or non-waste line? unknow.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.7.Was there spray or fluid under pressure no.".
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Search Alerts/Recalls
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