Catalog Number 343023 |
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 06/20/2022 |
Event Type
malfunction
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Event Description
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It has been reported that the bd facs calibur¿ has been found leaking uncontained waste fluid.The following has been provided by the initial reporter: please confirm the safety check below.Was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was there spray of fluid under pressure? no.What was the fluid that leaked? non biohazard.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination or bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.Liquid is leaking from below between the sheath tank and the waste liquid tank.When the flow is set to m or h, liquid leaks from around the flow cell.
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.It was determined the leakage was non-biohazard, therefore this is not considered to be a reportable malfunction.
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Event Description
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It has been reported that the bd facs calibur¿ has been found leaking uncontained waste fluid.The following has been provided by the initial reporter: please confirm the safety check below.1.Was the leak fluid or air¿ fluid.2.Was the leak contained within the instrument no.3.Was there spray of fluid under pressure? no.4.What was the fluid that leaked? non biohazard.5.Did biohazard leak before or after waste line? after waste line.6.Was the waste mixed with decontamination or bleach? no.7.Was the customer/bd personnel physically in contact with the fluid? no.Liquid is leaking from below between the sheath tank and the waste liquid tank.When the flow is set to m or h, liquid leaks from around the flow cell.
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Search Alerts/Recalls
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