FENWAL, INC. AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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Model Number X6R2326 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/30/2022 |
Event Type
malfunction
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Event Description
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Rn doing auto stem cell collection when the machine stopped at mid cycle 14 and alarmed noting centrifuge leak and blood all over the centrifuge.Leak noted at one of the chambers of the centrifuge pack of the kit used with lot #fa22g25121.Procedure aborted.Pic manager, bmt lab and company made aware.Manufacturer response for apheresis blood collection set, amicus mnc apheresis kit with double needle (per site reporter).Not known.
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Event Description
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Rn doing auto stem cell collection when the machine stopped at mid cycle 14 and alarmed noting centrifuge leak and blood all over the centrifuge.Leak noted at one of the chambers of the centrifuge pack of the kit used with lot #fa22g25121.Procedure aborted.Pic manager, bmt lab and company made aware.Manufacturer response for apheresis blood collection set, amicus mnc apheresis kit with double needle (per site reporter).Not known.
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