BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT III; SEE H.10
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Model Number 647205 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/15/2020 |
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.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).
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Event Description
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It was reported that during use with a bd facs¿ sample prep assistant iii waste was leaking outside of the instrument.The following information was provided by the initial reporter: flooding reported.Are you using this product for clinical diagnostic tests? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? no.Follow up required? n/a.Software version? (b)(4).List of parts shipped (include foc): n/a.Rma required? n/a.Was there a fluidic leak or spill? yes.No erroneous results, no one was injured in the making of this case & there were no burning smells or odd sounds.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? yes.What was the fluid that leaked/spilled? unknown.What is the source of leak/spill? (waste 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.Leak or drip was not under pressure.Additionally, on 2020-09-28 the fse provided the following additional information: leaking fluid was waste, it was a wash tower overflow (no bleach/decontaminate).
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Event Description
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It was reported that during use with a bd facs¿ sample prep assistant iii waste was leaking outside of the instrument.The following information was provided by the initial reporter: flooding reported.Are you using this product for clinical diagnostic tests? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Resolution achieved? no.Follow up required? n/a.Software version? 9.List of parts shipped (include foc): n/a.Rma required? n/a.Was there a fluidic leak or spill? yes.No erroneous results, no one was injured in the making of this case & there were no burning smells or odd sounds.1.Was the leak/spill contained within the instrument? no.2.Was the leak/spill in a customer accessible location? yes.3.What was the fluid that leaked/spilled? unknown.4.What is the source of leak/spill? (waste 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.Leak or drip was not under pressure.Additionally, on 2020-09-28 the fse provided the following additional information: leaking fluid was waste, it was a wash tower overflow (no bleach/decontaminate).
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Manufacturer Narrative
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H6: investigation summary: customer called to report the problem.Customer declined to troubleshoot the issue in favor of onsite service.Fse arrived on site, removed and cleaned waste pump.Tested system.The instrument is testing without errors and has been returned to the customer for normal use.The instrument is currently operational.Fluids were contained within the system.No one was exposed to any biological hazards or bodily fluids.Review of the dhr for serial number: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Root cause: based on the investigation results, the root cause was a clogged waste pump.H3 other text : see h.10.
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