Model Number LKT200 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation for this complaint is currently underway, but has not yet been completed.A follow-up report will be filed to reflect the results of the investigation.Internal document numbers are (b)(4).
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Event Description
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On (b)(6) 2020, organ recovery systems (ors) received a customer complaint that the lkt200 leaked fluid.The transplant center decided not to offer the kidney for transplantation.
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Manufacturer Narrative
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Although we could not duplicate the complainant's experience, capa-000059 has been initiated to address this failure mode associated with the rework of lot 119944.D4: unique identifier (udi) # has been corrected.Previous report indicated the di, but not the pi.
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Search Alerts/Recalls
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